title: Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage

acronym: T-STORHM

summary:
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.

T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.

ReferenceCitation: Spinella PC. Zero preventable deaths after traumatic injury: An achievable goal. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S2-S8. doi: 10.1097/TA.0000000000001425. No abstract available.

ReferenceCitation: Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Meta-analysis of plasma to red blood cell ratios and mortality in massive blood transfusions for trauma. Injury. 2013 Dec;44(12):1693-9. doi: 10.1016/j.injury.2012.07.193. Epub 2012 Sep 25.

ReferenceCitation: Johansson PI, Oliveri RS, Ostrowski SR. Hemostatic resuscitation with plasma and platelets in trauma. J Emerg Trauma Shock. 2012 Apr;5(2):120-5. doi: 10.4103/0974-2700.96479.

ReferenceCitation: Cap A, Hunt B. Acute traumatic coagulopathy. Curr Opin Crit Care. 2014 Dec;20(6):638-45. doi: 10.1097/MCC.0000000000000158.

ReferenceCitation: Cap AP, Pidcoke HF, Spinella P, Strandenes G, Borgman MA, Schreiber M, Holcomb J, Tien HC, Beckett AN, Doughty H, Woolley T, Rappold J, Ward K, Reade M, Prat N, Ausset S, Kheirabadi B, Benov A, Griffin EP, Corley JB, Simon CD, Fahie R, Jenkins D, Eastridge BJ, Stockinger Z. Damage Control Resuscitation. Mil Med. 2018 Sep 1;183(suppl_2):36-43. doi: 10.1093/milmed/usy112.

ReferenceCitation: Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, Komadina R, Maegele M, Nardi G, Riddez L, Samama CM, Vincent JL, Rossaint R. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019 Mar 27;23(1):98. doi: 10.1186/s13054-019-2347-3.

ReferenceCitation: Godier A, Bacus M, Kipnis E, Tavernier B, Guidat A, Rauch A, Drumez E, Susen S, Garrigue-Huet D. Compliance with evidence-based clinical management guidelines in bleeding trauma patients. Br J Anaesth. 2016 Nov;117(5):592-600. doi: 10.1093/bja/aew317.

ReferenceCitation: Stanworth SJ, Davenport R, Curry N, Seeney F, Eaglestone S, Edwards A, Martin K, Allard S, Woodford M, Lecky FE, Brohi K. Mortality from trauma haemorrhage and opportunities for improvement in transfusion practice. Br J Surg. 2016 Mar;103(4):357-65. doi: 10.1002/bjs.10052. Epub 2016 Feb 3.

ReferenceCitation: Carli P, Pons F, Levraut J, Millet B, Tourtier JP, Ludes B, Lafont A, Riou B. The French emergency medical services after the Paris and Nice terrorist attacks: what have we learnt? Lancet. 2017 Dec 16;390(10113):2735-2738. doi: 10.1016/S0140-6736(17)31590-8. Epub 2017 Jul 25. No abstract available.

ReferenceCitation: Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc. Erratum In: J Trauma Acute Care Surg. 2013 Feb;74(2):706. Kotwal, Russell S [corrected to Kotwal, Russ S].

ReferenceCitation: Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b.

ReferenceCitation: Glasgow S, Davenport R, Perkins Z, Tai N, Brohi K. A comprehensive review of blood product use in civilian mass casualty events. J Trauma Acute Care Surg. 2013 Sep;75(3):468-74. doi: 10.1097/TA.0b013e318298efb9. No abstract available.

ReferenceCitation: Doughty H, Glasgow S, Kristoffersen E. Mass casualty events: blood transfusion emergency preparedness across the continuum of care. Transfusion. 2016 Apr;56 Suppl 2:S208-16. doi: 10.1111/trf.13488.

ReferenceCitation: Glasgow SM, Allard S, Rackham R, Doughty H. Going for gold: blood planning for the London 2012 Olympic Games. Transfus Med. 2014 Jun;24(3):145-53. doi: 10.1111/tme.12116. Epub 2014 Apr 18.

ReferenceCitation: Glasgow SM, Allard S, Doughty H, Spreadborough P, Watkins E. Blood and bombs: the demand and use of blood following the London Bombings of 7 July 2005--a retrospective review. Transfus Med. 2012 Aug;22(4):244-50. doi: 10.1111/j.1365-3148.2012.01173.x.

ReferenceCitation: Radwan ZA, Bai Y, Matijevic N, del Junco DJ, McCarthy JJ, Wade CE, Holcomb JB, Cotton BA. An emergency department thawed plasma protocol for severely injured patients. JAMA Surg. 2013 Feb;148(2):170-5. doi: 10.1001/jamasurgery.2013.414.

ReferenceCitation: de Biasi AR, Stansbury LG, Dutton RP, Stein DM, Scalea TM, Hess JR. Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME). Transfusion. 2011 Sep;51(9):1925-32. doi: 10.1111/j.1537-2995.2010.03050.x. Epub 2011 Feb 18.

ReferenceCitation: Cardenas JC, Zhang X, Fox EE, Cotton BA, Hess JR, Schreiber MA, Wade CE, Holcomb JB; PROPPR Study Group. Platelet transfusions improve hemostasis and survival in a substudy of the prospective, randomized PROPPR trial. Blood Adv. 2018 Jul 24;2(14):1696-1704. doi: 10.1182/bloodadvances.2018017699.

ReferenceCitation: Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.

ReferenceCitation: Cap AP, Spinella PC, Borgman MA, Blackbourne LH, Perkins JG. Timing and location of blood product transfusion and outcomes in massively transfused combat casualties. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S89-94. doi: 10.1097/TA.0b013e318260625a.

ReferenceCitation: Fox EE, Holcomb JB, Wade CE, Bulger EM, Tilley BC; PROPPR Study Group. Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients. Shock. 2017 May;47(5):567-573. doi: 10.1097/SHK.0000000000000788.

ReferenceCitation: Novak DJ, Bai Y, Cooke RK, Marques MB, Fontaine MJ, Gottschall JL, Carey PM, Scanlan RM, Fiebig EW, Shulman IA, Nelson JM, Flax S, Duncan V, Daniel-Johnson JA, Callum JL, Holcomb JB, Fox EE, Baraniuk S, Tilley BC, Schreiber MA, Inaba K, Rizoli S, Podbielski JM, Cotton BA, Hess JR; PROPPR Study Group. Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial. Transfusion. 2015 Jun;55(6):1331-9. doi: 10.1111/trf.13098. Epub 2015 Mar 30.

ReferenceCitation: Daban JL, Kerleguer A, Clavier B, Salliol A, Ausset S. [Fresh whole blood transfusion for war surgery: the experience of the Kabul French combat support hospital from 2006 to 2009]. Ann Fr Anesth Reanim. 2012 Nov;31(11):850-6. doi: 10.1016/j.annfar.2012.07.014. Epub 2012 Sep 1. French.

ReferenceCitation: Esnault P, Cungi PJ, Romanat PE, D'Aranda E, Cotte J, Bordes J, Vichard A, Aguillon P, Sailliol A, Meaudre E. [Blood transfusion on battlefield. The Kabul hospital experience]. Ann Fr Anesth Reanim. 2013 Oct;32(10):670-5. doi: 10.1016/j.annfar.2013.06.007. Epub 2013 Aug 13. French.

ReferenceCitation: Ausset S, Meaudre E, Kaiser E, Sailliol A, Hugard L, Jeandel P. [Acute traumatic haemorrhagic shock and transfusion: the French army policy]. Ann Fr Anesth Reanim. 2009 Jul-Aug;28(7-8):707-9. doi: 10.1016/j.annfar.2009.05.011. Epub 2009 Jul 3. No abstract available. French.

ReferenceCitation: McGuigan R, Spinella PC, Beekley A, Sebesta J, Perkins J, Grathwohl K, Azarow K. Pediatric trauma: experience of a combat support hospital in Iraq. J Pediatr Surg. 2007 Jan;42(1):207-10. doi: 10.1016/j.jpedsurg.2006.09.020.

ReferenceCitation: Sailliol A, Clavier B, Cap A, Ausset S. [French European military haemovigilance guidelines]. Transfus Clin Biol. 2010 Dec;17(5-6):315-7. doi: 10.1016/j.tracli.2010.09.001. Epub 2010 Nov 3. French.

ReferenceCitation: Nair PM, Pidcoke HF, Cap AP, Ramasubramanian AK. Effect of cold storage on shear-induced platelet aggregation and clot strength. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S88-93. doi: 10.1097/TA.0000000000000327.

ReferenceCitation: Pidcoke HF, Spinella PC, Ramasubramanian AK, Strandenes G, Hervig T, Ness PM, Cap AP. Refrigerated platelets for the treatment of acute bleeding: a review of the literature and reexamination of current standards. Shock. 2014 May;41 Suppl 1:51-3. doi: 10.1097/SHK.0000000000000078.

ReferenceCitation: Nair PM, Pandya SG, Dallo SF, Reddoch KM, Montgomery RK, Pidcoke HF, Cap AP, Ramasubramanian AK. Platelets stored at 4 degrees C contribute to superior clot properties compared to current standard-of-care through fibrin-crosslinking. Br J Haematol. 2017 Jul;178(1):119-129. doi: 10.1111/bjh.14751. Epub 2017 Jun 4.

ReferenceCitation: Bahr MP, Yazer MH, Triulzi DJ, Collins RA. Whole blood for the acutely haemorrhaging civilian trauma patient: a novel idea or rediscovery? Transfus Med. 2016 Dec;26(6):406-414. doi: 10.1111/tme.12329. Epub 2016 Jun 29.

ReferenceCitation: Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0. Erratum In: Ann Surg. 2014 Jul;260(1):178.

ReferenceCitation: Jenkins D, Stubbs J, Williams S, Berns K, Zielinski M, Strandenes G, Zietlow S. Implementation and execution of civilian remote damage control resuscitation programs. Shock. 2014 May;41 Suppl 1:84-9. doi: 10.1097/SHK.0000000000000133.

ReferenceCitation: Stubbs JR, Zielinski MD, Jenkins D. The state of the science of whole blood: lessons learned at Mayo Clinic. Transfusion. 2016 Apr;56 Suppl 2(Suppl 2):S173-81. doi: 10.1111/trf.13501.

ReferenceCitation: Yazer MH, Jackson B, Sperry JL, Alarcon L, Triulzi DJ, Murdock AD. Initial safety and feasibility of cold-stored uncrossmatched whole blood transfusion in civilian trauma patients. J Trauma Acute Care Surg. 2016 Jul;81(1):21-6. doi: 10.1097/TA.0000000000001100.

ReferenceCitation: Seheult JN, Triulzi DJ, Alarcon LH, Sperry JL, Murdock A, Yazer MH. Measurement of haemolysis markers following transfusion of uncrossmatched, low-titre, group O+ whole blood in civilian trauma patients: initial experience at a level 1 trauma centre. Transfus Med. 2017 Feb;27(1):30-35. doi: 10.1111/tme.12372. Epub 2016 Oct 12.

ReferenceCitation: Savage SA, Zarzaur BL, Pohlman TH, Brewer BL, Magnotti LJ, Croce MA, Lim GH, Martin AC. Clot dynamics and mortality: The MA-R ratio. J Trauma Acute Care Surg. 2017 Oct;83(4):628-634. doi: 10.1097/TA.0000000000001637.

ReferenceCitation: Einersen PM, Moore EE, Chapman MP, Moore HB, Gonzalez E, Silliman CC, Banerjee A, Sauaia A. Rapid thrombelastography thresholds for goal-directed resuscitation of patients at risk for massive transfusion. J Trauma Acute Care Surg. 2017 Jan;82(1):114-119. doi: 10.1097/TA.0000000000001270.

ReferenceCitation: Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.

ReferenceCitation: Ince C, Boerma EC, Cecconi M, De Backer D, Shapiro NI, Duranteau J, Pinsky MR, Artigas A, Teboul JL, Reiss IKM, Aldecoa C, Hutchings SD, Donati A, Maggiorini M, Taccone FS, Hernandez G, Payen D, Tibboel D, Martin DS, Zarbock A, Monnet X, Dubin A, Bakker J, Vincent JL, Scheeren TWL; Cardiovascular Dynamics Section of the ESICM. Second consensus on the assessment of sublingual microcirculation in critically ill patients: results from a task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2018 Mar;44(3):281-299. doi: 10.1007/s00134-018-5070-7. Epub 2018 Feb 6.

ReferenceCitation: Tachon G, Harrois A, Tanaka S, Kato H, Huet O, Pottecher J, Vicaut E, Duranteau J. Microcirculatory alterations in traumatic hemorrhagic shock. Crit Care Med. 2014 Jun;42(6):1433-41. doi: 10.1097/CCM.0000000000000223.

ReferenceCitation: Tanaka S, Escudier E, Hamada S, Harrois A, Leblanc PE, Vicaut E, Duranteau J. Effect of RBC Transfusion on Sublingual Microcirculation in Hemorrhagic Shock Patients: A Pilot Study. Crit Care Med. 2017 Feb;45(2):e154-e160. doi: 10.1097/CCM.0000000000002064.

ReferenceCitation: Tanaka S, Harrois A, Nicolai C, Flores M, Hamada S, Vicaut E, Duranteau J. Qualitative real-time analysis by nurses of sublingual microcirculation in intensive care unit: the MICRONURSE study. Crit Care. 2015 Nov 6;19:388. doi: 10.1186/s13054-015-1106-3.

ReferenceCitation: Zatta AJ, McQuilten ZK, Mitra B, Roxby DJ, Sinha R, Whitehead S, Dunkley S, Kelleher S, Hurn C, Cameron PA, Isbister JP, Wood EM, Phillips LE; Massive Transfusion Registry Steering Committee. Elucidating the clinical characteristics of patients captured using different definitions of massive transfusion. Vox Sang. 2014 Jul;107(1):60-70. doi: 10.1111/vox.12121. Epub 2014 Apr 2.

ReferenceCitation: Godier A, Samama CM, Susen S. [Management of massive bleeding in 2013: seven questions and answers]. Transfus Clin Biol. 2013 May;20(2):55-8. doi: 10.1016/j.tracli.2013.02.015. Epub 2013 Apr 12. French.

ReferenceCitation: Hamada SR, Rosa A, Gauss T, Desclefs JP, Raux M, Harrois A, Follin A, Cook F, Boutonnet M; Traumabase(R) Group; Attias A, Ausset S, Boutonnet M, Dhonneur G, Duranteau J, Langeron O, Paugam-Burtz C, Pirracchio R, de St Maurice G, Vigue B, Rouquette A, Duranteau J. Development and validation of a pre-hospital "Red Flag" alert for activation of intra-hospital haemorrhage control response in blunt trauma. Crit Care. 2018 May 5;22(1):113. doi: 10.1186/s13054-018-2026-9.

ReferenceCitation: Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: simple as ABC (assessment of blood consumption)? J Trauma. 2009 Feb;66(2):346-52. doi: 10.1097/TA.0b013e3181961c35.

ReferenceCitation: Pommerening MJ, Goodman MD, Holcomb JB, Wade CE, Fox EE, Del Junco DJ, Brasel KJ, Bulger EM, Cohen MJ, Alarcon LH, Schreiber MA, Myers JG, Phelan HA, Muskat P, Rahbar M, Cotton BA; MPH on behalf of the PROMMTT Study Group. Clinical gestalt and the prediction of massive transfusion after trauma. Injury. 2015 May;46(5):807-13. doi: 10.1016/j.injury.2014.12.026. Epub 2015 Feb 4.

ReferenceCitation: Yazer MH, Delaney M, Doughty H, Dunbar NM, Al-Riyami AZ, Triulzi DJ, Watchko JF, Wood EM, Yahalom V, Emery SP. It is time to reconsider the risks of transfusing RhD negative females of childbearing potential with RhD positive red blood cells in bleeding emergencies. Transfusion. 2019 Dec;59(12):3794-3799. doi: 10.1111/trf.15569. Epub 2019 Oct 18. No abstract available.

ReferenceCitation: Martinaud C, Civadier C, Ausset S, Verret C, Deshayes AV, Sailliol A. In vitro hemostatic properties of French lyophilized plasma. Anesthesiology. 2012 Aug;117(2):339-46. doi: 10.1097/ALN.0b013e3182608cdd.

ReferenceCitation: Raux M, Le Manach Y, Gauss T, Baumgarten R, Hamada S, Harrois A, Riou B, Duranteau J, Langeron O, Mantz J, Paugam-Burtz C, Vigue B; TRAUMABASE Group. Comparison of the Prognostic Significance of Initial Blood Lactate and Base Deficit in Trauma Patients. Anesthesiology. 2017 Mar;126(3):522-533. doi: 10.1097/ALN.0000000000001490.

ReferenceCitation: Regnier MA, Raux M, Le Manach Y, Asencio Y, Gaillard J, Devilliers C, Langeron O, Riou B. Prognostic significance of blood lactate and lactate clearance in trauma patients. Anesthesiology. 2012 Dec;117(6):1276-88. doi: 10.1097/ALN.0b013e318273349d.

ReferenceCitation: Manikis P, Jankowski S, Zhang H, Kahn RJ, Vincent JL. Correlation of serial blood lactate levels to organ failure and mortality after trauma. Am J Emerg Med. 1995 Nov;13(6):619-22. doi: 10.1016/0735-6757(95)90043-8.

ReferenceCitation: Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9. doi: 10.1097/00005373-199310000-00014.

ReferenceCitation: Smith IM, Crombie N, Bishop JR, McLaughlin A, Naumann DN, Herbert M, Hancox JM, Slinn G, Ives N, Grant M, Perkins GD, Doughty H, Midwinter MJ; RePHILL Trial Collaborators. RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma. Transfus Med. 2018 Oct;28(5):346-356. doi: 10.1111/tme.12486. Epub 2017 Nov 28.

ReferenceCitation: Boutonnet M, Abback P, Le Sache F, Harrois A, Follin A, Imbert N, Cap AP, Trichereau J, Ausset S; Traumabase Group. Tranexamic acid in severe trauma patients managed in a mature trauma care system. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S54-S62. doi: 10.1097/TA.0000000000001880.

ReferenceCitation: Riou B, Thicoïpe M, Atain-Kouadio P, Carli P. Comment evaluer la gravité? In: France S de, editor. Actualités en réanimation préhospitalière, Paris: Société française d'éditions médicales; 2002.

ReferenceCitation: Duranteau J, Asehnoune K, Pierre S, Ozier Y, Leone M, Lefrant J-Y. Recommandations sur la réanimation du choc hémorragique. Anesthésie & Réanimation 2015;1:62-74. https://doi.org/10.1016/j.anrea.2014.12.007.

ReferenceCitation: Massive transfusion in trauma guidelines. American College of Surgeons. Quality improvement project: trauma resuscitation best practice guidelines. Chicago (IL): American College of Surgeons 2013.

ReferenceCitation: Miller RD. Massive blood transfusions: the impact of Vietnam military data on modern civilian transfusion medicine. Anesthesiology. 2009 Jun;110(6):1412-6. doi: 10.1097/ALN.0b013e3181a1fd54.

ReferenceCitation: Brohi K, Levy H, Boffard K, Riou B, Kiepert P, Zielske D. Normalization of lactate within 8 hours or ≥20% clearance in initial 2 hours correlates with outcomes from traumatic hemorrhagic shock. Critical Care Medicine 2011;39:177.

collaborators: TIMC-IMAG Floralis

sponsor_collaborators: Direction Centrale du Service de Santé des Armées

location_facility:
CHU de La Cavale Blanche - Brest
CHU de Grenoble
HIA Percy
CHU du Kremlin Bicêtre
HIA Sainte Anne
CHU de La Pitié-Salpêtrière


title: Interest of PET-PSMA Imaging Potentiated by Androgen Blockade in Patients With Biological Relapse or Persistent Biological Disease of a Localized Prostatic Adenocarcinoma After Initial Treatment

acronym: PREFAcE

summary: Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier de Grenoble Hôpital Nord Michallon

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study

acronym: DYNAMIC

summary:
The aim of the study is to compare a treatment with doxycycline vs a placebo as soon as the patient is confirmed COVID-19 + and before the onset of oxygen dependence with the aim of reducing or even abolishing the cytokine explosion and thus the evolution towards a serious form of the disease which can lead to death.

Three criteria support the rational use of tetrcycline in COVI-19 (1) The coronaviruses is known to bind to metalloproteases (MMPs) of the host, in particular to ensure viral survival. Tetracyclines are known to chelate zinc from MMPs. Their chelating activity may help inhibit COVID19 infection by limiting its ability to replicate in the host. (2) Tetracyclines may also be able to inhibit the replication of positive-polarity single-stranded RNA viruses, such as COVID19 (demonstrated on the dengue virus). (3) In addition, tetracyclines are modulators of innate immunity (anti-inflammatory activity), a property used in the treatment of inflammatory skin diseases for many years. These modulating effects are noted on several targets of innate immunity: They can decrease the expression of NFKB, the release of inflammatory cytokines such as TNF-α, IL-1β and IL-6, inhibit granulomas inflammatory and free radical release.

Tetracyclines could therefore participate in limiting the cytokine release induced by COVID19. Their lipophilic nature and their strong pulmonary penetration could allow them to inhibit viral replication.

status: Withdrawn

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nantes
CHU Grenoble
CHU Caen
CHU Bordeaux
CHU Dijon
CHU Avicenne - APHP

status_simplified: Unknown


title: Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19

summary:
This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection.

The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.

status: Completed

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Centre Hospitalier Intercommunal Villeneuve St Georges

location_facility:
Centre hospitalier de Melun (GHSIF)
CHI Créteil
Hopital universitaire de Hotel Dieu
Hopital Universitaire de Necker
CHI Villeneuve St Georges
CHU Henri Mondor

intervention_type: Other

status_simplified: Completed


title: Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases

acronym: PIMABOD

summary:
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.

Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre de Pneumologie Bordeaux Rive droite

intervention_type: Procedure


type: Other Identifier

title: Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study

acronym: COPE

summary:
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients.

For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B:

Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis)
Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).

primary_purpose: Other

lead_sponsor: Institut Bergonié

location_facility:
CHRU Brest
Institut Bergonie
Polyclinique Marzet
Centre hospitalier de la Côte Basque
Clinique Tivoli-Ducos
Polyclinique Bordeaux Nord Aquitaine

intervention_type: Genetic

lead_sponsor_type: industriel


title: Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older

acronym: MUCOVEINE

summary:
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.

Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.

Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.

This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital enfant la Timone - CRCM pédiatrique Marseille

intervention_type: Device

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: MUCOVEINE

titre: Efficacité d'une technique de visualisation par infra-rouge pour l'acces veineux périphérique chez les patients atteints de mucoviscidose âgés de 12 ans et plus

discipline_principale: pneumologie pédiatrie et

nom_porteur: GORIOT RAYNAUD

prenom_porteur: Nadege


title: A Multicentre, Open-label, Phase I-II Study Evaluating the Combination of a MEK Inhibitor and a PDL1 Inhibitor in Pediatric and Adult Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma.

acronym: COTESARC

summary: The proposed study conducted in adult and pediatric patients aims to evaluate the safety and clinical activity of atezolizumab + cobimetinib in advanced/metastatic soft tissue sarcomas (up to 80 patients).

location_facility:
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Institut Gustave Roussy
Hôpital de la Timone
Institut Curie


title: EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer

summary: 5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHRU Jean Minjoz
CH de Troyes
Polyclinique de Courlancy
CHU de Reims
CHU de Dijon
Centre Georges-François Leclerc


lead_sponsor: ABX advanced biochemical compounds GmbH

summary: This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

location_facility: Hôpitaux de Brabois (Vandoeuvre-les-Nancy)

title: Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer

source: euctr


title: Coats Plus Syndrome and LCC Syndrome: Series of 10 Pediatric Cases. Review of Literature and Natural History

acronym: COATS+

summary:
Coats plus syndrome is a very rare and serious disease, caused by premature telomere shortening. It is a pediatric, multi-systemic disease, the main features of which are retinal vasculopathy and neurological disorders, associated with brain calcification and leukodystrophy. Its precise genetic etiology was discovered in 2012: autosomal recessive mutation of the CTC1 gene.

Publications about this syndrome are very few, and consist only of case reports, or small series of cases. This is explained by the rarity of occurrence of this syndrome. Since 1988, 57 cases of Coats plus syndrome have been published, with case series of up to 13 patients. Only 28 cases were detailed concerning the precise clinical presentation in the literature.

The general characteristics of this syndrome are known and, in addition to the ophthalmological and neurological damage, the various publications have been able to report a digestive attack (hemorrhages), hematological damage (central cytopenias), or increased bone fragility. No treatment is currently available to cure patients.

The natural history of this disease is poorly known. However, the most accurate knowledge possible of this disease, and its natural history, is essential. It would allow an easier identification of this rare syndrome, the establishment of a management (monitoring and therapeutic) adapted, and a more accurate genetic counseling in case of need of a prenatal diagnosis.

The description of a new series of unpublished cases, as well as a comprehensive review of the literature on Coats plus syndrome, will provide a more comprehensive and informed view of this disease.

Moreover, LCC syndrome (leukoencephalopathy with calcifications and cysts) is an autosomal recessive disorder linked to a mutation in the SNORD118 gene, which has the particularity of presenting the same neurological (neuro-radiological and clinical) characteristics, but without associating the others. ophthalmological and systemic disorders. It constitutes the differential radiological diagnosis of Coats plus syndrome. In this, the collection of medical data of French pediatric cases presenting this syndrome will allow a more detailed analysis of the differences and similarities between these two syndromes.

time_perspective: Retrospective

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Limoges
Fondation Adolphe de ROTHSCHILD
CHU de Rennes
Hopital Robert Debré
Hopital Kremlin Bicêtre
Hospices civils de Lyon


type: EudraCT Number

title: Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes

acronym: ACCRAPAN

summary: This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. doi: 10.1007/s10549-006-9254-4. Epub 2006 May 17.

ReferenceCitation: Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.

ReferenceCitation: Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6.

ReferenceCitation: Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. doi: 10.1016/j.ygyno.2006.12.012. Epub 2007 Jan 29.

ReferenceCitation: Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8(1):146-55. doi: 10.1102/1470-7330.2008.0022.

ReferenceCitation: Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.

ReferenceCitation: Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12. doi: 10.1016/j.ijrobp.2004.03.035.

ReferenceCitation: Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.

ReferenceCitation: Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80. doi: 10.1200/JCO.2004.07.197.

ReferenceCitation: Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.

ReferenceCitation: Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.

ReferenceCitation: Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60. doi: 10.1016/s0360-3016(03)00325-0.

ReferenceCitation: Cihoric N, Tapia C, Kruger K, Aebersold DM, Klaeser B, Lossl K. IMRT with (1)(8)FDG-PET\CT based simultaneous integrated boost for treatment of nodal positive cervical cancer. Radiat Oncol. 2014 Mar 25;9:83. doi: 10.1186/1748-717X-9-83.

ReferenceCitation: Vargo JA, Kim H, Choi S, Sukumvanich P, Olawaiye AB, Kelley JL, Edwards RP, Comerci JT, Beriwal S. Extended field intensity modulated radiation therapy with concomitant boost for lymph node-positive cervical cancer: analysis of regional control and recurrence patterns in the positron emission tomography/computed tomography era. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1091-8. doi: 10.1016/j.ijrobp.2014.08.013. Epub 2014 Oct 8.

ReferenceCitation: Perry LJ, Mathews C, Nugent E, Farrell R, Zorn K, Moore K. Outcomes of cervical cancer and positive para-aortic lymph nodes in the modern era of chemoradiation. Int J Gynecol Cancer. 2014 Mar;24(3):564-9. doi: 10.1097/IGC.0000000000000093.

ReferenceCitation: Gouy S, Morice P, Narducci F, Uzan C, Martinez A, Rey A, Bentivegna E, Pautier P, Deandreis D, Querleu D, Haie-Meder C, Leblanc E. Prospective multicenter study evaluating the survival of patients with locally advanced cervical cancer undergoing laparoscopic para-aortic lymphadenectomy before chemoradiotherapy in the era of positron emission tomography imaging. J Clin Oncol. 2013 Aug 20;31(24):3026-33. doi: 10.1200/JCO.2012.47.3520. Epub 2013 Jul 15.

ReferenceCitation: Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.

ReferenceCitation: Mabuchi S, Morishige K, Fujita M, Tsutsui T, Sakata M, Enomoto T, Kimura T. The activity of carboplatin and paclitaxel for recurrent cervical cancer after definitive radiotherapy. Gynecol Oncol. 2009 May;113(2):200-4. doi: 10.1016/j.ygyno.2009.02.008. Epub 2009 Mar 6.

ReferenceCitation: Tinker AV, Bhagat K, Swenerton KD, Hoskins PJ. Carboplatin and paclitaxel for advanced and recurrent cervical carcinoma: the British Columbia Cancer Agency experience. Gynecol Oncol. 2005 Jul;98(1):54-8. doi: 10.1016/j.ygyno.2005.03.037.

ReferenceCitation: Mabuchi S, Morishige K, Enomoto T, Kimura T. Carboplatin and paclitaxel as an initial treatment in patients with stage IVb cervical cancer: a report of 7 cases and a review of the literature. J Gynecol Oncol. 2010 Jun;21(2):93-6. doi: 10.3802/jgo.2010.21.2.93. Epub 2010 Jun 30.

ReferenceCitation: Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Eur J Cancer. 2003 Nov;39(17):2470-86. doi: 10.1016/s0959-8049(03)00425-8.

ReferenceCitation: McCormack M, Kadalayil L, Hackshaw A, Hall-Craggs MA, Symonds RP, Warwick V, Simonds H, Fernando I, Hammond M, James L, Feeney A, Ledermann JA. A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer. Br J Cancer. 2013 Jun 25;108(12):2464-9. doi: 10.1038/bjc.2013.230. Epub 2013 May 21.

ReferenceCitation: Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008 Apr 17;358(16):1663-71. doi: 10.1056/NEJMoa0707056. Erratum In: N Engl J Med. 2008 Jul 3;359(1):106. N Engl J Med. 2009 Apr 16;360(16):1685.

ReferenceCitation: ELLIS RE. The distribution of active bone marrow in the adult. Phys Med Biol. 1961 Jan;5:255-8. doi: 10.1088/0031-9155/5/3/302. No abstract available.

ReferenceCitation: Vande Berg BC, Malghem J, Lecouvet FE, Maldague B. Magnetic resonance imaging of the normal bone marrow. Skeletal Radiol. 1998 Sep;27(9):471-83. doi: 10.1007/s002560050423.

ReferenceCitation: Platta CS, Bayliss A, McHaffie D, Tome WA, Straub MR, Bradley KA. A dosimetric analysis of tomotherapy based intensity modulated radiation therapy with and without bone marrow sparing in gynecologic malignancies. Technol Cancer Res Treat. 2013 Feb;12(1):19-29. doi: 10.7785/tcrt.2012.500300. Epub 2012 Sep 10.

ReferenceCitation: Mell LK, Kochanski JD, Roeske JC, Haslam JJ, Mehta N, Yamada SD, Hurteau JA, Collins YC, Lengyel E, Mundt AJ. Dosimetric predictors of acute hematologic toxicity in cervical cancer patients treated with concurrent cisplatin and intensity-modulated pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Dec 1;66(5):1356-65. doi: 10.1016/j.ijrobp.2006.03.018. Epub 2006 Jun 6.

ReferenceCitation: Chang Y, Yang ZY, Li GL, Li Q, Yang Q, Fan JQ, Zhao YC, Song YQ, Wu G. Correlations Between Radiation Dose in Bone Marrow and Hematological Toxicity in Patients With Cervical Cancer: A Comparison of 3DCRT, IMRT, and RapidARC. Int J Gynecol Cancer. 2016 May;26(4):770-6. doi: 10.1097/IGC.0000000000000660.

ReferenceCitation: Yang TJ, Oh JH, Apte A, Son CH, Deasy JO, Goodman KA. Clinical and dosimetric predictors of acute hematologic toxicity in rectal cancer patients undergoing chemoradiotherapy. Radiother Oncol. 2014 Oct;113(1):29-34. doi: 10.1016/j.radonc.2014.09.002. Epub 2014 Oct 7.

ReferenceCitation: Lujan AE, Mundt AJ, Yamada SD, Rotmensch J, Roeske JC. Intensity-modulated radiotherapy as a means of reducing dose to bone marrow in gynecologic patients receiving whole pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):516-21. doi: 10.1016/s0360-3016(03)00521-2.

ReferenceCitation: Lim K, Small W Jr, Portelance L, Creutzberg C, Jurgenliemk-Schulz IM, Mundt A, Mell LK, Mayr N, Viswanathan A, Jhingran A, Erickson B, De los Santos J, Gaffney D, Yashar C, Beriwal S, Wolfson A, Taylor A, Bosch W, El Naqa I, Fyles A; Gyn IMRT Consortium. Consensus guidelines for delineation of clinical target volume for intensity-modulated pelvic radiotherapy for the definitive treatment of cervix cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):348-55. doi: 10.1016/j.ijrobp.2009.10.075. Epub 2010 May 14.

ReferenceCitation: A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Pierre Curie
Centre Léonard de Vinci
Centre Hospitalier de Lens
Clinique des dentellières
Centre Oscar Lambret
Centre Marie Curie

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CLCC OSCAR LAMBRET LILLE

type_etablissement: CLCC

acronyme: ACCRAPAN

titre: Essai de phase II évaluant la chimiothérapie adjuvante hebdomadaire après une radio-chimiothérapie dans le traitement du cancer du col utérin localement avancé présentant des ganglions lombo-aortiques positifs

discipline_principale: cancer du col utéringanglions lombo-aortiquesradio-chimiothérapiechimiothérapie adjuvantecarboplatine-paclitaxel

nom_porteur: LE TINIER

prenom_porteur: Florence


title: Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

acronym: ChewingHort

summary: It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).

status: Unknown status

location_facility:
CH Avignon
CHU Limoges
CH St Antoine
CH Valenciennes
CHU Tours
CHU de Nantes


title: Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

acronym: SYNOFRESH

summary: To study the diagnostic performance of infrared spectroscopy on fresh synovial fluids in early septic arthritis diagnosis in patients with acute joint effusion

lead_sponsor: Rennes University Hospital

location_facility:
CHRU Brest
CHU Nantes
CHRU Tours
CHU Clermont-Ferrand
CHU de Rennes
CHU Angers

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: SYNOFRESH

titre: Utilisation de la spectroscopie infrarouge déportée pour le diagnostic d'arthrite septique.

discipline_principale: autre

nom_porteur: ALBERT

prenom_porteur: Jean-David


title: Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.

summary: The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with Cerebral Palsy (CP)

lead_sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

location_facility: Centre d'Education Motrice Jean-Marie Arnion - Odynéo

location_facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre d'Education Motrice Henry Gormand


title: Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers

acronym: PROMESSE

summary:
Prospective memory (PM) is the ability to implement intended actions in the future. It allows maintaining and retrieving future plans, goals, and activities (i.e., remember to remember). PM is associated with most everyday memory problems . PM is crucial to correctly respond to all the social, occupational and working demands of everyday life, to perform many deferred health-related actions and is involved in therapeutic adherence .

Indeed, PM errors are an important part of the aging memory complaints. The prevalence of self-reported PM failures is also significant among young adults, compared with self-reported retrospective memory (RM) failures .Yet, PM errors are major sources of frustration and embarrassment .

In oncology, recently investigated the self-reported memory complaints in a 80 case-healthy-control study breast patients . Subjective memory complaints were assessed using the Prospective and Retrospective Memory Questionnaire . Results from the Paquet et al. study show that all participants (i.e., both patients and matched-controls) reported more PM than RM failures in daily-life (p<.001). Breast cancer patients reported more RM and PM failures than controls. However, this group effect was no longer statistically significant when controlling for depression and fatigue.

These findings are consistent with the view that memory complaints are closely associated with depression and cancer-related fatigue, and more generally with psychopathological variables .As underlined by Paquet et al. subjective memory complaints should be investigated because they refer to some aspects of the cancer experience that could potentially be linked to quality of life. Thus, it is important to explore psychopathological basis such as depression, anxiety and fatigue while investigating self-reported memory failures in cancer patients.

Despites the importance of PM, there have been, to our knowledge, only few studies evaluating PM complaints or PM functioning in patients diagnosed with an intracerebral tumor (such as Diffuse Low-Grade Glioma- DLGG- or glioblastome- GB) or extra-cerebral tumor (such as breast cancer - BC). Therefore, the investigators thought it would be useful, as a first step, to conduct a study to explore and to manage the PM and RM subjective complaints in cancer patients compared to another chronic disease, such as HIV. In fine, these data will help to identify a new target for psychological management focused on either psychopathological or neuropsychological rehabilitation

primary_purpose: Supportive Care

ReferenceCitation: Bedard M, Verma S, Collins B, Song X, Paquet L. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test. J Psychosoc Oncol. 2016 Jul-Aug;34(4):291-304. doi: 10.1080/07347332.2016.1181133. Epub 2016 Apr 28.

ReferenceCitation: Boone M, Roussel M, Chauffert B, Le Gars D, Godefroy O. Prevalence and profile of cognitive impairment in adult glioma: a sensitivity analysis. J Neurooncol. 2016 Aug;129(1):123-30. doi: 10.1007/s11060-016-2152-7. Epub 2016 May 30.

ReferenceCitation: Brem S, Meyers CA, Palmer G, Booth-Jones M, Jain S, Ewend MG. Preservation of neurocognitive function and local control of 1 to 3 brain metastases treated with surgery and carmustine wafers. Cancer. 2013 Nov 1;119(21):3830-8. doi: 10.1002/cncr.28307. Epub 2013 Aug 23.

ReferenceCitation: Cheng H, Yang Z, Dong B, Chen C, Zhang M, Huang Z, Chen Z, Wang K. Chemotherapy-induced prospective memory impairment in patients with breast cancer. Psychooncology. 2013 Oct;22(10):2391-5. doi: 10.1002/pon.3291. Epub 2013 May 15.

ReferenceCitation: Crawford JR, Henry JD, Ward AL, Blake J. The Prospective and Retrospective Memory Questionnaire (PRMQ): latent structure, normative data and discrepancy analysis for proxy-ratings. Br J Clin Psychol. 2006 Mar;45(Pt 1):83-104. doi: 10.1348/014466505X28748.

ReferenceCitation: de Frias CM, Dixon RA, Backman L. Use of memory compensation strategies is related to psychosocial and health indicators. J Gerontol B Psychol Sci Soc Sci. 2003 Jan;58(1):P12-22. doi: 10.1093/geronb/58.1.p12.

ReferenceCitation: Dieckmann P, Reddersen S, Wehner T, Rall M. Prospective memory failures as an unexplored threat to patient safety: results from a pilot study using patient simulators to investigate the missed execution of intentions. Ergonomics. 2006 Apr 15-May 15;49(5-6):526-43. doi: 10.1080/00140130600568782.

ReferenceCitation: Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.

ReferenceCitation: Fleming J, Ownsworth T, Doig E, Hutton L, Griffin J, Kendall M, Shum DH. The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2017 Jan 5;18(1):3. doi: 10.1186/s13063-016-1758-6.

ReferenceCitation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

ReferenceCitation: Gentile S, Delaroziere JC, Favre F, Sambuc R, San Marco JL. Validation of the French 'multidimensional fatigue inventory' (MFI 20). Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64. doi: 10.1046/j.1365-2354.2003.00295.x.

ReferenceCitation: Gonneaud J, Kalpouzos G, Bon L, Viader F, Eustache F, Desgranges B. Distinct and shared cognitive functions mediate event- and time-based prospective memory impairment in normal ageing. Memory. 2011 May;19(4):360-77. doi: 10.1080/09658211.2011.570765.

ReferenceCitation: Guerdoux E, Dressaire D, Martin S, Adam S, Brouillet D. Habit and recollection in healthy aging, mild cognitive impairment, and Alzheimer's disease. Neuropsychology. 2012 Jul;26(4):517-33. doi: 10.1037/a0028718. Epub 2012 May 28.

ReferenceCitation: Guerdoux E, Martin S, Dressaire D, Adam S, Brouillet D. [Memory controlled processes between the young and old: the birth of cognitive complaint?]. Can J Aging. 2009 Mar;28(1):5-20. doi: 10.1017/S0714980809090023. French.

ReferenceCitation: Herrmann C. International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results. J Psychosom Res. 1997 Jan;42(1):17-41. doi: 10.1016/s0022-3999(96)00216-4.

ReferenceCitation: Kim HJ, Barsevick AM, Fang CY, Miaskowski C. Common biological pathways underlying the psychoneurological symptom cluster in cancer patients. Cancer Nurs. 2012 Nov-Dec;35(6):E1-E20. doi: 10.1097/NCC.0b013e318233a811.

ReferenceCitation: Kliegel M, Altgassen M, Hering A, Rose NS. A process-model based approach to prospective memory impairment in Parkinson's disease. Neuropsychologia. 2011 Jul;49(8):2166-77. doi: 10.1016/j.neuropsychologia.2011.01.024. Epub 2011 Jan 19.

ReferenceCitation: Kliegel M, Martin M, McDaniel MA, Einstein GO. Varying the importance of a prospective memory task: differential effects across time- and event-based prospective memory. Memory. 2001 Jan;9(1):1-11. doi: 10.1080/09658210042000003.

ReferenceCitation: Kvavilashvili L, Kornbrot DE, Mash V, Cockburn J, Milne A. Differential effects of age on prospective and retrospective memory tasks in young, young-old, and old-old adults. Memory. 2009 Feb;17(2):180-96. doi: 10.1080/09658210802194366.

ReferenceCitation: Lange M, Joly F. How to Identify and Manage Cognitive Dysfunction After Breast Cancer Treatment. J Oncol Pract. 2017 Dec;13(12):784-790. doi: 10.1200/JOP.2017.026286.

ReferenceCitation: Martin S, Mazzocco C, Maury P, Grosselin A, Van der Elst W, Dixon RA, Brouillet D. Compensating for memory losses throughout aging: validation and normalization of the memory compensation questionnaire (MCQ) for non-clinical French populations. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):28-38. doi: 10.1016/j.archger.2014.10.013. Epub 2014 Oct 22.

ReferenceCitation: Meyers CA, Wefel JS. The use of the mini-mental state examination to assess cognitive functioning in cancer trials: no ifs, ands, buts, or sensitivity. J Clin Oncol. 2003 Oct 1;21(19):3557-8. doi: 10.1200/JCO.2003.07.080. Epub 2003 Aug 11. No abstract available.

ReferenceCitation: Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.

ReferenceCitation: Paquet L, Collins B, Song X, Chinneck A, Bedard M, Verma S. A pilot study of prospective memory functioning in early breast cancer survivors. Breast. 2013 Aug;22(4):455-61. doi: 10.1016/j.breast.2013.04.002. Epub 2013 May 4.

ReferenceCitation: Paquet L, Verma S, Collins B, Chinneck A, Bedard M, Song X. Testing a novel account of the dissociation between self-reported memory problems and memory performance in chemotherapy-treated breast cancer survivors. Psychooncology. 2018 Jan;27(1):171-177. doi: 10.1002/pon.4389. Epub 2017 Feb 10.

ReferenceCitation: Woods SP, Moran LM, Dawson MS, Carey CL, Grant I; HIV Neurobehavioral Research Center (HNRC) Group. Psychometric characteristics of the memory for intentions screening test. Clin Neuropsychol. 2008 Sep;22(5):864-78. doi: 10.1080/13854040701595999.

ReferenceCitation: Razavi D, Delvaux N, Farvacques C, Robaye E. Screening for adjustment disorders and major depressive disorders in cancer in-patients. Br J Psychiatry. 1990 Jan;156:79-83. doi: 10.1192/bjp.156.1.79.

ReferenceCitation: Scullin MK, McDaniel MA, Shelton JT. The Dynamic Multiprocess Framework: evidence from prospective memory with contextual variability. Cogn Psychol. 2013 Aug-Sep;67(1-2):55-71. doi: 10.1016/j.cogpsych.2013.07.001. Epub 2013 Aug 3.

ReferenceCitation: Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.

ReferenceCitation: Smith G, Della Sala S, Logie RH, Maylor EA. Prospective and retrospective memory in normal ageing and dementia: a questionnaire study. Memory. 2000 Sep;8(5):311-21. doi: 10.1080/09658210050117735.

ReferenceCitation: Smith T, Gildeh N, Holmes C. The Montreal Cognitive Assessment: validity and utility in a memory clinic setting. Can J Psychiatry. 2007 May;52(5):329-32. doi: 10.1177/070674370705200508.

ReferenceCitation: Woods SP, Carey CL, Moran LM, Dawson MS, Letendre SL, Grant I; HIV Neurobehavioral Research Center (HNRC) Group. Frequency and predictors of self-reported prospective memory complaints in individuals infected with HIV. Arch Clin Neuropsychol. 2007 Feb;22(2):187-95. doi: 10.1016/j.acn.2006.12.006. Epub 2007 Feb 6.

ReferenceCitation: Zeintl M, Kliegel M, Rast P, Zimprich D. Prospective memory complaints can be predicted by prospective memory performance in older adults. Dement Geriatr Cogn Disord. 2006;22(3):209-15. doi: 10.1159/000094915. Epub 2006 Aug 7.

ReferenceCitation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
Hopital saint Louis
CHU Lyon
UFR de Psychologie Université de Lille
Hôpital d'Instruction des Armées
Icm Val D'Aurelle
CHU D'amiens


title: Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial

acronym: RESECT COLON

summary:
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.

location_facility:
Nancy University Hospital
University Hospital, Limoges
Edouard Herriot Hospital
Jean Mermoz Hospital
Cochin Hospital
Pontchaillou Hospital

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

type_etablissement: CH

acronyme: RESECT-COLON

titre: Dissection sous-muqueuse endoscopique (ESD) versus mucosectomie piece-meal pour les adénomes non pédiculés de grande taille : un essai contrôlé randomisé

discipline_principale: gastroenterology

nom_porteur: JACQUES

prenom_porteur: Jeremie


title: A Sorafenib-Regorafenib Sequence Treatment Monitoring Study Using Liquid Biopsy

acronym: HELP

summary: The aim of this trial is to investigate whether quantitative analysis of the total concentration of circulating free deoxyribonucleic acid (cfDNA) and of the cfDNA integrity index (DII) (Intplex®) may reflect hepatocellular carcinoma (HCC) tumor dynamics or response for patients treated by Sorafenib or Regorafenib and if it could be used as a tool for patient management under targeted therapy.

status: Terminated

ReferenceCitation: Gupta S, Bent S, Kohlwes J. Test characteristics of alpha-fetoprotein for detecting hepatocellular carcinoma in patients with hepatitis C. A systematic review and critical analysis. Ann Intern Med. 2003 Jul 1;139(1):46-50. doi: 10.7326/0003-4819-139-1-200307010-00012.

ReferenceCitation: Riaz A, Ryu RK, Kulik LM, Mulcahy MF, Lewandowski RJ, Minocha J, Ibrahim SM, Sato KT, Baker T, Miller FH, Newman S, Omary R, Abecassis M, Benson AB 3rd, Salem R. Alpha-fetoprotein response after locoregional therapy for hepatocellular carcinoma: oncologic marker of radiologic response, progression, and survival. J Clin Oncol. 2009 Dec 1;27(34):5734-42. doi: 10.1200/JCO.2009.23.1282. Epub 2009 Oct 5.

ReferenceCitation: Chan SL, Mo FK, Johnson PJ, Hui EP, Ma BB, Ho WM, Lam KC, Chan AT, Mok TS, Yeo W. New utility of an old marker: serial alpha-fetoprotein measurement in predicting radiologic response and survival of patients with hepatocellular carcinoma undergoing systemic chemotherapy. J Clin Oncol. 2009 Jan 20;27(3):446-52. doi: 10.1200/JCO.2008.18.8151. Epub 2008 Dec 8.

ReferenceCitation: Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouilleres O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including alpha-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

ReferenceCitation: Personeni N, Bozzarelli S, Pressiani T, Rimassa L, Tronconi MC, Sclafani F, Carnaghi C, Pedicini V, Giordano L, Santoro A. Usefulness of alpha-fetoprotein response in patients treated with sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2012 Jul;57(1):101-7. doi: 10.1016/j.jhep.2012.02.016. Epub 2012 Mar 10.

ReferenceCitation: Yamashita T, Forgues M, Wang W, Kim JW, Ye Q, Jia H, Budhu A, Zanetti KA, Chen Y, Qin LX, Tang ZY, Wang XW. EpCAM and alpha-fetoprotein expression defines novel prognostic subtypes of hepatocellular carcinoma. Cancer Res. 2008 Mar 1;68(5):1451-61. doi: 10.1158/0008-5472.CAN-07-6013.

ReferenceCitation: Sozzi G, Conte D, Mariani L, Lo Vullo S, Roz L, Lombardo C, Pierotti MA, Tavecchio L. Analysis of circulating tumor DNA in plasma at diagnosis and during follow-up of lung cancer patients. Cancer Res. 2001 Jun 15;61(12):4675-8.

ReferenceCitation: Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, Gillet B, Gongora C, Dechelotte P, Robert B, Del Rio M, Lamy PJ, Bibeau F, Nouaille M, Loriot V, Jarrousse AS, Molina F, Mathonnet M, Pezet D, Ychou M. Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Nat Med. 2014 Apr;20(4):430-5. doi: 10.1038/nm.3511. Epub 2014 Mar 23.

ReferenceCitation: Thierry AR, El Messaoudi S, Gahan PB, Anker P, Stroun M. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Sep;35(3):347-76. doi: 10.1007/s10555-016-9629-x.

ReferenceCitation: Ono A, Fujimoto A, Yamamoto Y, Akamatsu S, Hiraga N, Imamura M, Kawaoka T, Tsuge M, Abe H, Hayes CN, Miki D, Furuta M, Tsunoda T, Miyano S, Kubo M, Aikata H, Ochi H, Kawakami YI, Arihiro K, Ohdan H, Nakagawa H, Chayama K. Circulating Tumor DNA Analysis for Liver Cancers and Its Usefulness as a Liquid Biopsy. Cell Mol Gastroenterol Hepatol. 2015 Jun 17;1(5):516-534. doi: 10.1016/j.jcmgh.2015.06.009. eCollection 2015 Sep.

ReferenceCitation: Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.

ReferenceCitation: Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21.

ReferenceCitation: El Messaoudi S, Mouliere F, Du Manoir S, Bascoul-Mollevi C, Gillet B, Nouaille M, Fiess C, Crapez E, Bibeau F, Theillet C, Mazard T, Pezet D, Mathonnet M, Ychou M, Thierry AR. Circulating DNA as a Strong Multimarker Prognostic Tool for Metastatic Colorectal Cancer Patient Management Care. Clin Cancer Res. 2016 Jun 15;22(12):3067-77. doi: 10.1158/1078-0432.CCR-15-0297. Epub 2016 Feb 4.

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says Open Access)

host_type: publisher

license: unspecified-oa

license_normalized: unspecified-oa

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Zonta E, Nizard P, Taly V. Assessment of DNA Integrity, Applications for Cancer Research. Adv Clin Chem. 2015;70:197-246. doi: 10.1016/bs.acc.2015.03.002. Epub 2015 Apr 11.

sponsor_collaborators: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
Hôpital Hôtel Dieu
CHRU de Lille - Hôpital Claude Duriez
CHRU Nancy - Hôpital Brabois
Hôpital Saint-Eloi
Hôpital Beaujon
CHU Grenoble - Hôpital Michalon


title: "Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"

acronym: CONTICARE

summary:
There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS.

The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.

location_facility:
Clinic Jules Verne
CHU de Poitiers
CHD Vendée
CHU de Tours
APHP-Hôpital Beaujon
CHU Angers

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: CONTICARE

titre: Evaluation de l'intérêt de la prééducation périnéale par biofeedback dans la prévention des troubles fonctionnels défécatoires après résection rectale pour cancer.

nom_porteur: MEURETTE

prenom_porteur: Guillaume


title: Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial

summary: Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. The investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop UO. In the present study, the investigators examined the value and beneficial effects of early multidimensional management (MM) on prognosis. The investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94% had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p<0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis.

ReferenceType: derived

ReferenceCitation: Caplain S, Chenuc G, Blancho S, Marque S, Aghakhani N. Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. Front Neurol. 2019 Sep 4;10:929. doi: 10.3389/fneur.2019.00929. eCollection 2019.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

lead_sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale

location_facility:
Chu Bichat/Beaujon
Chu Montpellier
CHU St ANTOINE
Chu Bicetre
Chu Tenon
Chu Rouen


title: Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging

acronym: ACTIDEP

summary: Old age (> 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. The investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with MDD. Having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with MDD and can be routinely used in a day-to-day medical practice.

location_facility: CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale

location_facility: Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte

location_facility: Service de Radiologie- Neuroradiologie,CHU bretonneau

location_facility: Centre Mémoire de Ressources et de Recherche (CMRR),

location_facility: CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie


title: TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up

acronym: TIPIC-UNV

summary: TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

intervention_type: Diagnostic Test


title: Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study

acronym: CALVI

summary:
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.

Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Association des foulées de la Haute Lozère

collaborators: Connaître et Combattre les Myélodysplasies

location_facility:
Centre Léon Bérard
Chu Clermont-Ferrand
Institut de Cancérologie de la Loire
CH Jacques Lacarin
Chu Limoges
Centre Hospitalier Métropole Savoie


title: Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography

acronym: DOCTA

summary: This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.

time_perspective: Other

lead_sponsor: Aquitania Opthalmologica

location_facility:
CHU Nantes
CHU Nice
CHU Bordeaux
CHU Dijon
CHU Strasbourg
Hôpital de la Croix-Rousse


title: Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years

acronym: Steinert

summary: The aim of this study is to determine the factors associated with alveolar hypoventilation in terms of cognitive impairment, daytime sleepiness, respiratory function, nocturnal respiratory events This evaluation will clarify the clinical phenotypes of respiratory disease in myotonic steinert dystrophy.

lead_sponsor: University Hospital, Lille

location_facility: Chu de Nantes :Site Hôtel-Dieu- Hme - Nantes 1


title: Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals

acronym: AGAPO

summary: There is currently no consensus on the adequate concomitant treatment to apomorphine pump in Parkinson's disease (PD). In practice, some centers withdraw all dopaminergic agonists when initiating apomorphine pump therapy, whereas others combine the two. To date, there has been no study led to determine the best strategy for efficiently treating motor and nonmotor symptoms, as well as improving patients' quality of life (QoL). This preliminary study, entitled AGAPO, aims at identifying significant differences in patients' evolution (nonmotor symptoms and quality of life), over a course of 6 months, depending on the two strategies adopted in French centers (apomorphine pump with or without dopaminergic agonists), through the Non Motor Symptoms Scale (NMSS, Chaudhuri et al, 2017).

location_facility:
CH Caremeau
Hôpital Gui de Chauliac
CHU de Reims- hôpital Maison Blanche
CHU Charles Nicolle
CHU de Rennes
CHU La Pitié Salpêtrière


title: Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

acronym: OCRIS

summary: This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Pitié Salpêtrière University Hospital (APHP)


title: Multi-Omics and IPSCs to Improve the Diagnosis of Rare Intellectual Disabilities

acronym: MIDRID

summary:
Background Genetic factors play a major role in intellectual disability (ID) but the underlying cause is not determined in many cases.

This proposal is the continuation of the previous interregional project HUGODIMS, the aim of which was to perform whole exome sequencing (WES) in 69 thoroughly selected simplex ID parent-child trios. Thanks to HUGODIMS consortium, the underlying genetic cause of ID was determined or highly suspected in 48 cases (69.5%) and 7 novel ID genes were identified.

Hypothesis Investigators hypothesize that an approach combining genomics, transcriptomics, metabolomics and morphological analyses performed on induced pluripotent stem cell (iPSC)-derived neural cells would improve diagnosis of ID. The current proposal is therefore a proof-of concept project aiming at assessing the relevance and effectiveness of this multi-omics approach.

Aims and Methods Ten individuals with ID recruited through HUGODIMS, in whom WES have failed to identify pathogenic variants will be included.

The workflow is the following:

Whole genome sequencing (WGS) (Nantes) of these 10 negative trios.
Bio-informatics analyses

In 3 WGS negative cases, 3 positive controls bearing distinct mutations in CAMK2a (a novel ID gene identified thanks to HUGODIMS), and 3 healthy negative controls:

Derivation of induced pluripotent stem cell (iPSC)-derived neural progenitors (iPSC core facility at Nantes)
Targeted and non-targeted metabolomics analyses performed on iPSC-derived neuronal cells (Angers)
RNA sequencing performed on the 9 cell lines (Rennes)
Morphological analyses of differentiated neuronal cell lines derived from 3 affected individuals and 3 positive controls bearing CMK2a mutations (Tours)
Integration and validation of data from multi-omics and morphological approaches

Expected results and impact Investigatrors expect that this approach combining multi-omics and iPSC will help to improve diagnosis and understanding of genetic ID of unknown cause

lead_sponsor: University Hospital, Angers

location_facility:
CHU Nantes
CHU de Bourgogne
CHU Rennes
CHU Poitiers
HCL Lyon
CHU Angers


title: Universal Haplotype-Based Non Invasive Prenatal Diagnosis by Linked-Read Sequencing (10XGenomics™ Technology)

acronym: NID

summary:
Description of the presence of cell-free fetal DNA in maternal plasma allowed the possibility of non-invasive prenatal diagnosis. Whereas detection of paternally-inherited alleles is straightforward and being quickly implemented in routine, detection of maternally-inherited alleles remains challenging.

To date, the main approach that is being developped, called Relative Haplotype Dosage Analysis, relies on the identification of an allelic imbalance between the mother's wild-type and mutant alleles, relative to the fetal's contribution. This approach therefore requires the study of a propositus to identify the morbid haplotype, which is not always possible in the context of an ongoing pregnancy.

In this study, we aim to evaluate the contribution of new technologies, such as linked-read Sequencing, to allow direct identification of parental haplotype in the context of non-invasive prenatal diagnosis.

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Brest
CHRU de Dijon
CH Saint Brieuc
CHU de Rennes
CHU de Nantes
CHU de Rouen


title: The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

acronym: REVER

summary:
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.

For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).

Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.

Patients will be followed during the 3 cycles of treatment.

lead_sponsor: Institut Claudius Regaud

location_facility:
Clinique Capio La Croix Du Sud
Clinique Claude Bernard
Centre Hospitalier Auch
Clinique Pasteur
IUCT-O
Centre Hospitalier de Rodez


title: Teaching the Basics of Electroencephalography to Critical Care Teams

summary:
Knowledge of the basic fundamental skills of electroencephalography would enable medical and nursing staffs to provide efficient and effective bedside EEG monitoring in critically ill patients.

The aim of this study is to evaluate the ability of a 10-points EEG teaching program to allow bedside caregivers (medical and nursing intensive care unit staff) interpreting EEG in the critical care setting.

ReferenceCitation: Legriel S, Jacq G, Lalloz A, Geri G, Mahaux P, Bruel C, Brochon S, Zuber B, Andre C, Dervin K, Holleville M, Cariou A. Teaching Important Basic EEG Patterns of Bedside Electroencephalography to Critical Care Staffs: A Prospective Multicenter Study. Neurocrit Care. 2021 Feb;34(1):144-153. doi: 10.1007/s12028-020-01010-5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: Ictal Group

sponsor_collaborators:
Ictal Group
Versailles Hospital

location_facility: Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital

location_facility: Medico-Surgical Intensive Care Unit - Saint Joseph Hospital

location_facility: Medical Intensive Care Unit - Cochin Teaching Hospital

location_facility: Department of Anesthesia and Critical Care, Beaujon Hospital

location_facility: Intensive Care Unit - Versailles Hospital


title: Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV

acronym: AES ODEFSEY

summary:
Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV.

At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.

lead_sponsor: Nantes University Hospital

location_facility:
La Roche sur Yon Hospital
Nantes University Hospital
Le Mans Hospital
Angers University Hospital
Saint-Nazaire Hospital
Laval Hospital


title: Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).

acronym: MOTIVATE

summary:
This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.

The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

The study data (immune-related adverse events) will be collected during each administration of the treatment.

A questionnaire will be completed by the patient before the treatment administrations.

Patients will be followed until disease progression or up to 12 months of treatment.

ReferenceCitation: Cabarrou B, Gomez-Roca C, Viala M, Rabeau A, Paulon R, Loirat D, Munsch N, Delord JP, Filleron T. Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial. Invest New Drugs. 2020 Dec;38(6):1879-1887. doi: 10.1007/s10637-020-00938-x. Epub 2020 May 7.

location_facility: Institut Regional Du Cancer de Montpellier (Icm)

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections

acronym: VECAR

summary: The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.

primary_purpose: Prevention

location_facility:
CHU Toulouse
Hôpital Pitié Salpêtrière
CHU Rennes
CHU Bordeaux
CHU Lille
CHU Angers

acronyme: vecar

titre: Etude des effets bénéfiques de la ventilation mécanique durant la chirurgie cardiaque avec circulation extracorporelle sur la survenue des infections postopératoires

discipline_principale: cardiologie

nom_porteur: TADIÉ

prenom_porteur: Jean Marc


title: Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.

summary: Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.

ipd_sharing: Undecided

lead_sponsor: Octapharma

location_facility: CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque


title: Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)

summary:
This study is a phase I/II, multicenter, open-label study starting with a phase I part followed by a Phase II part.

The phase I part of the study aims at evaluating the safety and efficacy (in terms of abscopal effect at week 6) of the treatment combination schema of Stereotactic Body Radiation Therapy (SBRT) and PD-1 plus CTLA-4 inhibitors in patients with metastatic melanoma. Patients will be assigned in one of 3 cohorts depending the metastatic site. 18 patients will be enrolled in each cohort.

Once the recommended optimal radiotherapy dose has been declared for the 3 cohorts, patients will be enrolled in the phase II part of the study in order to evaluate the activity (progression-free survival at 6 months) of SBRT given in combination with immune checkpoints inhibitors in patients with metastatic melanoma.

66 patients will be included in the phase II.

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Combination Product


type: Registry Identifier

title: Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis in Hematological Patients

acronym: MYCOGENIE

summary: The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invasive aspergillosis (IA). DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance.

ReferenceCitation: Suarez F, Lortholary O, Buland S, Rubio MT, Ghez D, Mahe V, Quesne G, Poiree S, Buzyn A, Varet B, Berche P, Bougnoux ME. Detection of circulating Aspergillus fumigatus DNA by real-time PCR assay of large serum volumes improves early diagnosis of invasive aspergillosis in high-risk adult patients under hematologic surveillance. J Clin Microbiol. 2008 Nov;46(11):3772-7. doi: 10.1128/JCM.01086-08. Epub 2008 Sep 24.

ReferenceCitation: Dannaoui E, Gabriel F, Gaboyard M, Lagardere G, Audebert L, Quesne G, Godichaud S, Verweij PE, Accoceberry I, Bougnoux ME. Molecular Diagnosis of Invasive Aspergillosis and Detection of Azole Resistance by a Newly Commercialized PCR Kit. J Clin Microbiol. 2017 Nov;55(11):3210-3218. doi: 10.1128/JCM.01032-17. Epub 2017 Aug 16.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Société ADEMTECH SA

location_facility: Hôpital Necker - Enfants maladies (AP-HP)


title: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine

summary:
Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.

The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position

ReferenceCitation: Falempin AS, Pereira B, Binakdane F, Bazin JE, Smirdec M. Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25 degrees head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

location_facility:
Pôle Santé République
Polyclinique Saint Odilon
Hôpital Nord-Ouest
Hôpital Saint-Louis / AP-HP
CHU Clermont-Ferrand
Centre Hospitalier Alpes-Léman


title: Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment

acronym: IPIO-PA

summary: The increasingly used oral anticancer treatments allow the patient to reduce treatment and social constraints to reduce hospitalization costs. The counterpart is a decrease in the monitoring of the correct intake of drugs and the detection of side effects. These two risks are major in the elderly, due to comorbidities, poly-medication and decreased attention. The project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes for 3 months, compared to a conventional management without a nursing visit. It is a prospective, randomized, controlled, multicenter study to include 224 patients over 18 months. The impact will be assessed by counting the tablets not taken and by filling an observation booklet with the nurse at home.

location_facility:
ICO Angers
CHD Vendée
ICO Nantes
Hôpital privé du Confluent
CH Saint Nazaire
CHU de Nantes


title: MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?

summary:
This study concerns elderly patients with cancer with onco-geriatric assessment.

This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.

lead_sponsor: Centre Francois Baclesse

collaborators: UCOG (Unite de coordination en Onco-Gériatrie)

location_facility:
Ch Compiegne
CHU
CH
Centre Hospitalier
Centre François Baclesse
Centre Henri Becquerel


title: Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study

summary: Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.

ReferenceCitation: Billeaud C, Adamon L, Piloquet H, Hays NP, Dupuis L, Metreau I, Leke A. A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life. Front Pediatr. 2022 Sep 28;10:937882. doi: 10.3389/fped.2022.937882. eCollection 2022.

lead_sponsor: Société des Produits Nestlé (SPN)

sponsor_collaborators:
Société des Produits Nestlé (SPN)
Biofortis Mérieux NutriSciences

location_facility: CHU Bordeaux - Hôpital Pellegrin Enfants


title: Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway

acronym: PARACT

summary: The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care

ReferenceCitation: Verot E, Bouleftour W, Macron C, Rivoirard R, Chauvin F. Effect of PARACT (PARAmedical Interventions on Patient ACTivation) on the Cancer Care Pathway: Protocol for Implementation of the Patient Activation Measure-13 Item (PAM-13) Version. JMIR Res Protoc. 2020 Dec 8;9(12):e17485. doi: 10.2196/17485.

publisher_dissemination: JMIR Publications

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Clinique de l'infirmerie protestante de Lyon

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

intervention_type: Behavioral

nom_etablissement: CHU DE SAINT-ETIENNE

acronyme: PARACT

titre: Étude du rôle des para-médicaux sur l'activation du patient dans le parcours de soins en cancérologie

discipline_principale: gynécologie

nom_porteur: RIVOIRARD

prenom_porteur: Romain


title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study

acronym: RECO-Sepsis

summary:
Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.

ReferenceCitation: Cour M, Klouche K, Souweine B, Quenot JP, Schwebel C, Perinel S, Amaz C, Buisson M, Ovize M, Mewton N, Argaud L; RECO-Sepsis Trial Investigators. Remote ischemic conditioning in septic shock: the RECO-Sepsis randomized clinical trial. Intensive Care Med. 2022 Nov;48(11):1563-1572. doi: 10.1007/s00134-022-06872-1. Epub 2022 Sep 14.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL

ReferenceCitation: Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L. Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials. 2019 May 22;20(1):281. doi: 10.1186/s13063-019-3406-4.

lead_sponsor: Hospices Civils de Lyon

location_facility:
CH de Roanne
CHU de Saint-Etienne
CHU de Clermont-Ferrand
CHU de Montpellier
Hôpital Edouard Herriot
CHU de Grenoble

acronyme: RECO-Sepsis

titre: Conditionnement ischémique dans le choc septique (REmote ischemic COnditioning in septic shock)

discipline_principale: hors cancer

nom_porteur: COUR

prenom_porteur: Martin


title: Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

acronym: SAPPRO

summary: The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de clermont-Ferrand
CHU de Lille
CHU Nimes
CHU de Montpellier
Clinique Beau-Soleil
HFME - Hospices Civils de Lyon


title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures

acronym: STEP

summary:
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

However, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles.

The investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.

ReferenceCitation: Goueffic Y, Picquet J, Schneider F, Kaladji A, Marret O, Muller L, Guyomarc'h B, Riche VP, Chaillou P, Guillou M, Nasr B. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1883-1892. doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13.

location_facility:
CHU de Poitiers
CH de Cholet
CHD La Roche-sur-Yon
CHU Brest
CHU de Rennes
CHU Angers


title: Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial

acronym: ChimioPal

summary: The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.

study_start_date_type: Anticipated

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre