title: Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Two-part Clinical Study. PartA: Multisite MRI Acquisition, Protocol Harmonization. PartB: Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Clinical Study

summary:
THE STUDY WILL BE A TWO-PART RESEARCH

PART A and PART A extended:

To implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners).
Apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients.

PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and neurophysiological data in Mild Cognitive Impairment patient, we aim to:

To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) which is more sensitive than the changes observed in the loss of hippocampal volume (primary endpoint) and correlate with the neuropsychological progression and conversion (clinical secondary endpoints).
To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) at baseline which is more predictive of the loss of hippocampal volume (primary endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI patients.
To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe

ReferenceCitation: Grady CL, Haxby JV, Horwitz B, Sundaram M, Berg G, Schapiro M, Friedland RP, Rapoport SI. Longitudinal study of the early neuropsychological and cerebral metabolic changes in dementia of the Alzheimer type. J Clin Exp Neuropsychol. 1988 Oct;10(5):576-96.

lead_sponsor: Qualissima

location_country: Spain Italy Greece Netherlands France Germany

location_facility: APHM, Hopital de la Timone, Service de Neurologie et Neuropsychologie

location_facility: IRCCS Fondazione SDN per la Ricerca e l'Alta Formazione in Diagnostica Nucleare di Napoli

location_facility: Institut d'Investigacions Biomèdiques August Pi I Sunyer, IDIBAPS

location_facility: Hospital and Institute of the University of Duisburg and Essen - Department for Psychiatry and Psychotherapy, LVR Hospital Essen

location_facility: Aristotle University of Thessaloniki, Greek Association of Alzheimer's disease and related disorders, Thessaloniki, Greece

location_facility: IRCCS-FBF - Ordine Ospedaliero San Giovanni di Dio, Fatebenefratelli, Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Università Cattolica del Sacro Cuore - Policlinico Agostino Gemelli Istituto di Neurologia - Neuropsychological and Neurorehabilitation Unit

location_facility: Université Lille 2, UL2 - Centre d'investigation clinique / Centre de Ressources biologiques 9301 - INSERM - Centre Hospitalier Régional et Universitaire de LILLE

location_facility: University Hospital of Leipzig - Department of Psychiatry

location_facility: Neurofisiologia Clinica IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Padiglione Specialita' piano Fondi

location_facility: Dipartimento di Specialità medico-chirurgiche e Sanità Pubblica, Sezione di Clinica Neurologica, Centro Disturbi della Memoria, Perugia, Italy


type: Other Identifier

title: Safety of a Management Strategy Based on Colour Doppler ULTrasound and D-Dimer Testing for the Diagnosis Exclusion of RECurrent Deep Vein Thrombosis of the Lower Limbs. The ULTREC Project

acronym: ULTREC

summary:
The purpose is to assess the safety of a management strategy based on colour doppler ultrasound (CDUS) and D-Dimer test results for the diagnosis exclusion of recurrent deep vein thrombosis (DVT) of the lower limbs.

DVT recurrence requires using anticoagulant treatment to prevent thrombosis progression. Given an increased bleeding risk with prolonged treatment, an accurate diagnosis for recurrence is needed. However, the diagnosis of a new thrombosis in a previously involved leg is difficult. Imaging modalities and criteria that are currently used for the diagnosis may be equivocal and unable to discriminate between an old clot and a new one recently developed at the same site. An increase in vein diameter after vein compression by the ultrasound probe was suggested as a diagnostic criterion for a new DVT. This method has many limitations in clinical practice, mainly a lack of availability of a previous measurement and a poor inter-observer agreement.

Colour Doppler ultrasound enables to study both the thrombus and the blood flow characteristics that might help to overcome these limitations. CDUS is a well-known method for the diagnosis of vascular diseases and is used in every day clinical practice for the diagnosis of a first DVT and DVT recurrence but CDUS has never been assessed for DVT recurrence in a study. The diagnosis of DVT recurrence may be easily established using the same criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely rule out the diagnosis of DVT recurrence while maintaining a good specificity.

The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal CDUS, a D-Dimer test is performed. If the D-dimer is normal, the diagnosis of DVT recurrence is ruled out and the patient is not treated. If the D-dimer is abnormal, the diagnosis cannot be excluded nor confirmed and a second CDUS is performed on D7±2. Meanwhile, patients are not treated by anticoagulants. An unchanged CDUS on D7±2 qualifies patients as free from a new DVT and they are not treated. Conversely a change in CDUS qualifies patients as having a new DVT which requires anticoagulant treatment.

All patients have a 3-month follow-up for the assessment of potential venous thromboembolic events.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: background

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ReferenceCitation: Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4.

ReferenceCitation: Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.

ReferenceCitation: Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98.

ReferenceCitation: Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340. Review.

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ReferenceCitation: Hassen S, Barrellier MT, Seinturier C, Bosson JL, Genty C, Long A, Pernod G. High percentage of non-diagnostic compression ultrasonography results and the diagnosis of ipsilateral recurrent proximal deep vein thrombosis: a rebuttal. J Thromb Haemost. 2011 Feb;9(2):414-6; author reply 417-8. doi: 10.1111/j.1538-7836.2010.04137.x.

ReferenceCitation: Heijboer H, Jongbloets LM, Büller HR, Lensing AW, ten Cate JW. Clinical utility of real-time compression ultrasonography for diagnostic management of patients with recurrent venous thrombosis. Acta Radiol. 1992 Jul;33(4):297-300.

ReferenceCitation: Hull RD, Carter CJ, Jay RM, Ockelford PA, Hirsch J, Turpie AG, Zielinsky A, Gent M, Powers PJ. The diagnosis of acute, recurrent, deep-vein thrombosis: a diagnostic challenge. Circulation. 1983 Apr;67(4):901-6.

ReferenceCitation: Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum in: Chest. 2016 Oct;150(4):988.

ReferenceCitation: Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Perrier A, Bounameaux H. Value of D-dimer testing for the exclusion of pulmonary embolism in patients with previous venous thromboembolism. Arch Intern Med. 2006 Jan 23;166(2):176-80.

ReferenceCitation: Le Gal G, Kovacs MJ, Carrier M, Do K, Kahn SR, Wells PS, Anderson DA, Chagnon I, Solymoss S, Crowther M, Righini M, Perrier A, White RH, Vickars L, Rodger M. Validation of a diagnostic approach to exclude recurrent venous thromboembolism. J Thromb Haemost. 2009 May;7(5):752-9. doi: 10.1111/j.1538-7836.2009.03324.x. Epub 2009 Feb 18.

ReferenceCitation: Linkins LA, Stretton R, Probyn L, Kearon C. Interobserver agreement on ultrasound measurements of residual vein diameter, thrombus echogenicity and Doppler venous flow in patients with previous venous thrombosis. Thromb Res. 2006;117(3):241-7. Epub 2005 Mar 21.

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ReferenceCitation: Prandoni P, Lensing AW, Bernardi E, Villalta S, Bagatella P, Girolami A; DERECUS Investigators Group. The diagnostic value of compression ultrasonography in patients with suspected recurrent deep vein thrombosis. Thromb Haemost. 2002 Sep;88(3):402-6.

ReferenceCitation: Prandoni P, Tormene D, Dalla Valle F, Concolato A, Pesavento R. D-dimer as an adjunct to compression ultrasonography in patients with suspected recurrent deep vein thrombosis. J Thromb Haemost. 2007 May;5(5):1076-7. Epub 2007 Mar 15.

ReferenceCitation: Rathbun SW, Whitsett TL, Raskob GE. Negative D-dimer result to exclude recurrent deep venous thrombosis: a management trial. Ann Intern Med. 2004 Dec 7;141(11):839-45.

ReferenceCitation: Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Lärfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group. N Engl J Med. 1997 Feb 6;336(6):393-8.

ReferenceCitation: Tan M, Velthuis SI, Westerbeek RE, VAN Rooden CJ, VAN DER Meer FJ, Huisman MV. High percentage of non-diagnostic compression ultrasonography results and the diagnosis of ipsilateral recurrent proximal deep vein thrombosis. J Thromb Haemost. 2010 Apr;8(4):848-50. doi: 10.1111/j.1538-7836.2010.03758.x.

ReferenceCitation: Tan M, Bornais C, Rodger M. Interobserver reliability of compression ultrasound for residual thrombosis after first unprovoked deep vein thrombosis. J Thromb Haemost. 2012 Sep;10(9):1775-82. doi: 10.1111/j.1538-7836.2012.04827.x.

ReferenceCitation: Tan M, Mol GC, van Rooden CJ, Klok FA, Westerbeek RE, Iglesias Del Sol A, van de Ree MA, de Roos A, Huisman MV. Magnetic resonance direct thrombus imaging differentiates acute recurrent ipsilateral deep vein thrombosis from residual thrombosis. Blood. 2014 Jul 24;124(4):623-7. doi: 10.1182/blood-2014-04-566380. Epub 2014 Jun 13.

ReferenceCitation: van der Hulle T, Tan M, den Exter PL, van Roosmalen MJ, van der Meer FJ, Eikenboom J, Huisman MV, Klok FA. Recurrence risk after anticoagulant treatment of limited duration for late, second venous thromboembolism. Haematologica. 2015 Feb;100(2):188-93. doi: 10.3324/haematol.2014.112896. Epub 2014 Sep 26.

ReferenceCitation: Westerbeek RE, Van Rooden CJ, Tan M, Van Gils AP, Kok S, De Bats MJ, De Roos A, Huisman MV. Magnetic resonance direct thrombus imaging of the evolution of acute deep vein thrombosis of the leg. J Thromb Haemost. 2008 Jul;6(7):1087-92. doi: 10.1111/j.1538-7836.2008.02986.x. Epub 2008 Jul 1.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre hospitalier Universitaire Cavale Blanche

location_facility: Centre Hospitalier Universitaire Rangueil

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire François Mitterrand

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Cabinet libéral Besancon - polyclinique des Fleurs

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre de medicine vasculaire interventionnel

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management

acronym: VERONE

summary: This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_facility: CH de Saint-Malo - Hôpital Broussais /ID# 169935

location_facility: CH Cannes - les Broussailles /ID# 201108

location_facility: AP-HM - Hopital de la Conception /ID# 201981

location_facility: CHU Grenoble - Hopital Michallon /ID# 170741

location_facility: CH Roubaix - Hopital Victor Provo /ID# 170909

location_facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 170722

location_facility: Centre Hospitalier de Perpignan /ID# 170743

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941

location_facility: Hopital d'Instruction des Armées PERCY /ID# 170740

location_facility: CH de la Haute-Saône - Vesoul /ID# 205150

location_facility: CHR Orleans - Hopital de la Source /ID# 169453

location_facility: CH Pontoise - Hopital René Dubos /ID# 170720

location_facility: CHRU de Brest - Hopital Morvan /ID# 169457

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 170855

location_facility: Centre Hospitalier de CHOLET /ID# 171215

location_facility: Clinique Pole santé République /ID# 204658

location_facility: CHU Reims - Hôpital Robert Debre /ID# 170917

location_facility: CHU Amiens-Picardie Site Sud /ID# 170724

location_facility: CHU de La Réunion sites Sud - Saint-Pierre /ID# 204093

location_facility: CH Libourne - Hopital Robert Boulin /ID# 170739

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 200192

location_facility: Institut de Cancérologie du Gard /ID# 171207

location_facility: Centre Hospitalier de la Cote /ID# 170735

location_facility: CHU Strasbourg - Hopital Civil /ID# 200195

location_facility: Hopital Saint Vincent de Paul /ID# 169956

location_facility: CH Annecy Genevois Site Annecy /ID# 200826

location_facility: Centre Hospitalier de Versailles André Mignot /ID# 169950

location_facility: CHRU Tours - Hopital Bretonneau /ID# 169469

location_facility: CH Cornouailles - Site Quimper-Laennec /ID# 169937

location_facility: CH de Bourg-en Bresse - Hopital Fleyriat /ID# 170017

location_facility: CH CARCASSONNE - Antoine Gayraud /ID# 202530

location_facility: CH Pontoise - Hopital René Dubos /ID# 201329

location_facility: Institut de Cancérologie du Gard /ID# 169975

location_facility: CHU de Besancon - Jean Minjoz /ID# 170721

location_facility: CHI POISSY-ST GERMAIN - Centre de Coordination en Cancérologie /ID# 169966

lead_sponsor_type: industriel


type: EudraCT Number

title: A Randomized Multicenter Phase III Trial Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST)

acronym: ImadGist

summary:
This is a 2 arms study concerning patients with primary GIST who followed an Imatinib adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.

In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to determine if the continuation of this treatment is efficient for disease control, in terms of Disease Free Survival improvement.

In the second arm, patients will discontinue the Imatinib treatment, as standard practice. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Blackstein ME, Blay JY, Corless C, Driman DK, Riddell R, Soulières D, Swallow CJ, Verma S; Canadian Advisory Committee on GIST. Gastrointestinal stromal tumours: consensus statement on diagnosis and treatment. Can J Gastroenterol. 2006 Mar;20(3):157-63.

ReferenceCitation: Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, Joensuu H. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008 Feb 1;26(4):620-5. doi: 10.1200/JCO.2007.13.4403.

ReferenceCitation: Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.

ReferenceCitation: Blay JY, von Mehren M, Blackstein ME. Perspective on updated treatment guidelines for patients with gastrointestinal stromal tumors. Cancer. 2010 Nov 15;116(22):5126-37. doi: 10.1002/cncr.25267. Review.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13.

ReferenceCitation: Casali PG, Jost L, Reichardt P, Schlemmer M, Blay JY; ESMO Guidelines Working Group. Gastrointestinal stromal tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii35-8. doi: 10.1093/annonc/mdn080.

ReferenceCitation: ClinicalTrials.gov. Imatinib mesilate or observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor. NCT identifier: NCT00103168. 13-12-2009. Ref Type: Online Source

ReferenceCitation: ClinicalTrials.gov. Five year adjuvant imatinib mesilate (Gleevec®) in gastrointestinal stromal tumor (GIST). NCT Identifier: NCT00867113. 24-8-2011. Ref Type: Online Source

ReferenceCitation: Corless CL, Heinrich MC. Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol. 2008;3:557-86. Review.

ReferenceCitation: Corless CL, Barnett CM, Heinrich MC. Gastrointestinal stromal tumours: origin and molecular oncology. Nat Rev Cancer. 2011 Nov 17;11(12):865-78. doi: 10.1038/nrc3143. Review.

ReferenceCitation: Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. doi: 10.1016/S0140-6736(09)60500-6. Epub 2009 Mar 18. Erratum in: Lancet. 2009 Aug 8;374(9688):450.

ReferenceCitation: DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan;231(1):51-8.

ReferenceCitation: Dematteo RP, Heinrich MC, El-Rifai WM, Demetri G. Clinical management of gastrointestinal stromal tumors: before and after STI-571. Hum Pathol. 2002 May;33(5):466-77.

ReferenceCitation: Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80.

ReferenceCitation: Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2:S1-41; quiz S42-4.

ReferenceCitation: Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Pérol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.

ReferenceCitation: Gold JS, Gönen M, Gutiérrez A, Broto JM, García-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28.

ReferenceCitation: H.Joensuu, M.Eriksson, J.Hatrmann, K.Sundby Hall, J.Schutte, A. Reichardt, M.Schlemmer, E. Wardelmann, G.Ramadori, S. E. Al-Batran B. E. Nilsson O. Monge R. Kallio, and M.Sarlomo-Rikala, P. Bono M. Leinonen P. Hohenberger T. Alvegard P. Reichardt. Three years of imatinib improves survival for high-risk gastrointestinal stromal tumours. ASCO 2011 . 2011. Ref Type: Abstract

ReferenceCitation: Heinrich MC, Corless CL, Demetri GD, Blanke CD, von Mehren M, Joensuu H, McGreevey LS, Chen CJ, Van den Abbeele AD, Druker BJ, Kiese B, Eisenberg B, Roberts PJ, Singer S, Fletcher CD, Silberman S, Dimitrijevic S, Fletcher JA. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol. 2003 Dec 1;21(23):4342-9.

ReferenceCitation: Hirota S, Isozaki K, Moriyama Y, Hashimoto K, Nishida T, Ishiguro S, Kawano K, Hanada M, Kurata A, Takeda M, Muhammad Tunio G, Matsuzawa Y, Kanakura Y, Shinomura Y, Kitamura Y. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science. 1998 Jan 23;279(5350):577-80.

ReferenceCitation: Jiang WZ, Guan GX, Lu HS, Yang YH, Kang DY, Huang HG. Adjuvant imatinib treatment after R0 resection for patients with high-risk gastrointestinal stromal tumors: a median follow-up of 44 months. J Surg Oncol. 2011 Dec;104(7):760-4. doi: 10.1002/jso.22010. Epub 2011 Jun 28.

ReferenceCitation: Joensuu,H. and Ericksson,M.H.J. (2011). Twelve versus 36 monts of adjuvant imatinib as treatment of operable GIST with high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). J. Clin. Oncol.

ReferenceCitation: Joensuu H, Vehtari A, Riihimäki J, Nishida T, Steigen SE, Brabec P, Plank L, Nilsson B, Cirilli C, Braconi C, Bordoni A, Magnusson MK, Linke Z, Sufliarsky J, Federico M, Jonasson JG, Dei Tos AP, Rutkowski P. Risk of recurrence of gastrointestinal stromal tumour after surgery: an analysis of pooled population-based cohorts. Lancet Oncol. 2012 Mar;13(3):265-74. doi: 10.1016/S1470-2045(11)70299-6. Epub 2011 Dec 6. Review.

ReferenceCitation: Le Cesne,A., Ray-Coquard,I.L., Bui Nguyen,B., Adenis,A., Rios,M., Bertucci,F., Duffaud,F., Cupissol,D., Chevreau,C., Bompas,E., Cioffi,A., Chabaud,S., Perol,D., and Blay,J. (2011). Time to secondary resistance (TSR) after interruption of imatinib (IM) in advanced GIST: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival. ASCO Meeting Abstracts 29, 10015.

ReferenceCitation: Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Pérol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.

ReferenceCitation: Pisters PW, Colombo C. Adjuvant imatinib therapy for gastrointestinal stromal tumors. J Surg Oncol. 2011 Dec;104(8):896-900. doi: 10.1002/jso.22002. Review.

ReferenceCitation: Ray-Coquard,I.L., Bin Bui,N., Adenis,A., Rios,M., Bertucci,F., Chabaud,S., Perol,D., Blay,J., Le Cesne,A., and Groupe Sarcome Francais & Groupe d'Etude des Tumeurs Osseuses (GSF-GETO) (2010). Risk of relapse with imatinib (IM) discontinuation at 5 years in advanced GIST patients: Results of the prospective BFR14 randomized phase III study comparing interruption versus continuation of IM at 5 years of treatment: A French Sarcoma Group Study. ASCO Meeting Abstracts 28, 10032.

ReferenceCitation: Tryggvason G, Gíslason HG, Magnússon MK, Jónasson JG. Gastrointestinal stromal tumors in Iceland, 1990-2003: the icelandic GIST study, a population-based incidence and pathologic risk stratification study. Int J Cancer. 2005 Nov 1;117(2):289-93.

ReferenceCitation: Tzen CY, Wang JH, Huang YJ, Wang MN, Lin PC, Lai GL, Wu CY, Tzen CY. Incidence of gastrointestinal stromal tumor: a retrospective study based on immunohistochemical and mutational analyses. Dig Dis Sci. 2007 Mar;52(3):792-7.

ReferenceCitation: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34.

lead_sponsor: Centre Leon Berard

location_facility: Centre Régional de Lutte contre le Cancer de Montpellier

location_facility: Institut de cancérologie LUCIEN NEUWIRTH

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Centre Hospitalier universitaire Robert Debré

intervention_type: Drug


title: Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors

acronym: SBRT

summary: The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

ReferenceCitation: Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001.

ReferenceCitation: Rapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000.

ReferenceCitation: Rapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006.

ReferenceCitation: Maranzano E, Anselmo P, Casale M, Trippa F, Carletti S, Principi M, Loreti F, Italiani M, Caserta C, Giorgi C. Treatment of recurrent glioblastoma with stereotactic radiotherapy: long-term results of a mono-institutional trial. Tumori. 2011 Jan-Feb;97(1):56-61.

ReferenceCitation: Minniti G, Armosini V, Salvati M, Lanzetta G, Caporello P, Mei M, Osti MF, Maurizi RE. Fractionated stereotactic reirradiation and concurrent temozolomide in patients with recurrent glioblastoma. J Neurooncol. 2011 Jul;103(3):683-91. doi: 10.1007/s11060-010-0446-8. Epub 2010 Nov 5.

ReferenceCitation: Torok JA, Wegner RE, Mintz AH, Heron DE, Burton SA. Re-irradiation with radiosurgery for recurrent glioblastoma multiforme. Technol Cancer Res Treat. 2011 Jun;10(3):253-8.

ReferenceCitation: Zacharoulis S, Ashley S, Moreno L, Gentet JC, Massimino M, Frappaz D. Treatment and outcome of children with relapsed ependymoma: a multi-institutional retrospective analysis. Childs Nerv Syst. 2010 Jul;26(7):905-11. doi: 10.1007/s00381-009-1067-4. Epub 2009 Dec 29.

ReferenceCitation: Kano H, Yang HC, Kondziolka D, Niranjan A, Arai Y, Flickinger JC, Lunsford LD. Stereotactic radiosurgery for pediatric recurrent intracranial ependymomas. J Neurosurg Pediatr. 2010 Nov;6(5):417-23. doi: 10.3171/2010.8.PEDS10252.

ReferenceCitation: Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.

ReferenceCitation: Combs SE, Behnisch W, Kulozik AE, Huber PE, Debus J, Schulz-Ertner D. Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma. BMC Cancer. 2007 Sep 13;7:177.

ReferenceCitation: Giller CA, Berger BD, Pistenmaa DA, Sklar F, Weprin B, Shapiro K, Winick N, Mulne AF, Delp JL, Gilio JP, Gall KP, Dicke KA, Swift D, Sacco D, Harris-Henderson K, Bowers D. Robotically guided radiosurgery for children. Pediatr Blood Cancer. 2005 Sep;45(3):304-10.

ReferenceCitation: Grabb PA, Lunsford LD, Albright AL, Kondziolka D, Flickinger JC. Stereotactic radiosurgery for glial neoplasms of childhood. Neurosurgery. 1996 Apr;38(4):696-701; discussion 701-2.

ReferenceCitation: Hodgson DC, Goumnerova LC, Loeffler JS, Dutton S, Black PM, Alexander E 3rd, Xu R, Kooy H, Silver B, Tarbell NJ. Radiosurgery in the management of pediatric brain tumors. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):929-35.

ReferenceCitation: Chawla S, Schell MC, Milano MT. Stereotactic body radiation for the spine: a review. Am J Clin Oncol. 2013 Dec;36(6):630-6. doi: 10.1097/COC.0b013e31822dfd71. Review.

ReferenceCitation: Lo SS, Sahgal A, Wang JZ, Mayr NA, Sloan A, Mendel E, Chang EL. Stereotactic body radiation therapy for spinal metastases. Discov Med. 2010 Apr;9(47):289-96. Review.

ReferenceCitation: Siva S, MacManus M, Ball D. Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. J Thorac Oncol. 2010 Jul;5(7):1091-9. doi: 10.1097/JTO.0b013e3181de7143. Review.

ReferenceCitation: Fogh SE, Andrews DW, Glass J, Curran W, Glass C, Champ C, Evans JJ, Hyslop T, Pequignot E, Downes B, Comber E, Maltenfort M, Dicker AP, Werner-Wasik M. Hypofractionated stereotactic radiation therapy: an effective therapy for recurrent high-grade gliomas. J Clin Oncol. 2010 Jun 20;28(18):3048-53. doi: 10.1200/JCO.2009.25.6941. Epub 2010 May 17. Erratum in: J Clin Oncol. 2010 Sep 20;28(27):4280.

ReferenceCitation: Flannery T, Kano H, Martin JJ, Niranjan A, Flickinger JC, Lunsford LD, Kondziolka D. Boost radiosurgery as a strategy after failure of initial management of pediatric primitive neuroectodermal tumors. J Neurosurg Pediatr. 2009 Mar;3(3):205-10. doi: 10.3171/2008.11.PEDS08268.

ReferenceCitation: Conter C, Carrie C, Bernier V, Geoffray A, Pagnier A, Gentet JC, Lellouch-Tubiana A, Chabaud S, Frappaz D. Intracranial ependymomas in children: society of pediatric oncology experience with postoperative hyperfractionated local radiotherapy. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1536-42. doi: 10.1016/j.ijrobp.2008.09.051. Epub 2009 Apr 11.

ReferenceCitation: Massimino M, Gandola L, Giangaspero F, Sandri A, Valagussa P, Perilongo G, Garrè ML, Ricardi U, Forni M, Genitori L, Scarzello G, Spreafico F, Barra S, Mascarin M, Pollo B, Gardiman M, Cama A, Navarria P, Brisigotti M, Collini P, Balter R, Fidani P, Stefanelli M, Burnelli R, Potepan P, Podda M, Sotti G, Madon E; AIEOP Pediatric Neuro-Oncology Group. Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: final results of the first prospective AIEOP (Associazione Italiana di Ematologia-Oncologia Pediatrica) study. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1336-45.

ReferenceCitation: Sharma MS, Kondziolka D, Khan A, Kano H, Niranjan A, Flickinger JC, Lunsford LD. Radiation tolerance limits of the brainstem. Neurosurgery. 2008 Oct;63(4):728-32; discussion 732-3. doi: 10.1227/01.NEU.0000325726.72815.22.

ReferenceCitation: Merchant TE, Boop FA, Kun LE, Sanford RA. A retrospective study of surgery and reirradiation for recurrent ependymoma. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):87-97. doi: 10.1016/j.ijrobp.2007.09.037.

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

intervention_type: Radiation

status_simplified: Completed


title: Transcatheter Patent Foramen Ovale (PFO) Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Between 60 and 80 Years Old : a Randomised Controlled Trial.

summary: To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital de la Timone
APHP Hôpital Lariboisière
Groupe Hospitalier Paris Saint-Joseph
CHU Toulouse-Hôpital Pierre Paul Riquet
CHU Côte de Nacre
CHRU La Cavale Blanche
CHU Amiens
Hôpital Hautepierre
Hôpital Gui de Chauliac
Hôpital Pitié Salpêtrière
GHU Paris Psychiatrie et Neurosciences
CHU Bicêtre
APHP Hôpital Bichat
CHRU Nancy-Hôpital central
CH Yves Le Foll
CH Grenoble-Site Nord
CHU Bordeaux - GH Pellegrin
CH Arras
CHRU Lille-Hôpital Salengro
CH Perpignan
HCL-Groupement Hospitalier Lyon Est
Fondation Adolphe de Rothschild
CHU La Milétrie
CHU Saint-Etienne-Hôpital Nord
CHU Jean Minjoz
CHU Carémeau
CHU Rouen-Hôpital Charles-Nicolle
CH Versailles-Hôpital Mignot
CHU Dijon-Hôpital François Mitterrand
CHU Nantes-Hôpital Nord Laennec
Hôpital Henri Mondor

intervention_type: Procedure


title: Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters

acronym: COLAGE

summary: A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.

primary_purpose: Other

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hôpital des Diaconnesses Croix Saint Simon


title: Aquagenic Pruritus in Myeloproliferative Neoplasms

acronym: PANAM

summary:
Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.

status: Unknown status

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

status_simplified: Unknown


status: Terminated

title: A Multicenter Open-Label Study on the Safety and Efficacy of Deflazacort (Emflaza) in Subjects With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)

lead_sponsor: PTC Therapeutics

source: euctr

location_country:
Denmark
Russian Federation
Canada
Sweden
United States
France
Norway
Germany

location_facility: Rigshospitalet, University of Copenhagen

location_facility: Ludwig-Maximilians University Munich, Friedrich-Baur-Institute

location_facility: Washington University School of Medicine

location_facility: Pirogov Russian National Research Medical University

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hugo W Moser Research Institute at Kennedy Krieger Institute

summary: This study is designed to evaluate the safety and efficacy of deflazacort in participants with LGMD2I. Most participants enrolled will have a screening visit and 3 additional visits (after 1, 13, and 26 weeks of treatment).


acronym: MISTRAL

title: A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis

lead_sponsor: Hoffmann-La Roche

location_facility: Hopital National; Nephrologie Hemodialyse

location_facility: Hopital De La Maison Blanche; Nephrologie Hemodialyse

location_facility: Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse

location_facility: Ch Du Cotentin Site De Cherbourg; Nephrologie

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: Unite Autodialyse Paris 14; Dialyse A Domicile

location_facility: Chu La Miletrie;Nephrologie Transplantation

location_facility: Ch Pitie Salpetriere; Nephrologie Hemodialyse

location_facility: Hopital Clemenceau; Nephrologie Hemodialyse

location_facility: Hopital Bichat Claude Bernard; Nephrologie

location_facility: Ch Georges Renon; Nephrologie Hemodialyse

location_facility: Hôpital Des Brousailles; Service de Néphrologie

location_facility: Hopital Marc Jacquet; Nephrologie Hemodialyse

location_facility: CH de Saintonge; Unite 1 Med Interne Nephrologie

location_facility: Hopital de La Source; Service de Nephrologie & Hemodialyse

location_facility: Hopital Calmette; Medecine General & Nephrologie Serv.

location_facility: Hopital Manchester; Nephrologie Hemodialyse

location_facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse

location_facility: HOPITAL NORD; NEPH Transplantation Reanimation

location_facility: CH Bretagne Atlantique de Vannes; Hemodialyse

summary: This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.


title: IN.PACT™ Quality of Life Post-Reimbursement Study

summary: To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

lead_sponsor: Medtronic

location_facility: Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil

location_facility: Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare

intervention_type: Combination Product


title: Aged European Population QUality of Life in Infectious Diseases

acronym: AEQUI

summary:
The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts.

Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life and disability in aged populations has not been accurately quantified in a European setting.

This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Grenoble

location_country: France Spain Italy

location_facility: Groupement Hospitalier portes de Provence

location_facility: Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6

location_facility: FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San Carlos

location_facility: FCRB - Fundació Clínic per a la Recerca Biomèdica

location_facility: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

location_facility: FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

location_facility: Centre Hospitalier Intercommunal de Villeneuve St Georges.

location_facility: Ospedale Civile di Dolo- ULSS 3 "Serenissima"

location_facility: Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia

location_facility: Azienda Ospedaliera Universitaria Policlinico di Palermo

location_facility: Unità Operativa Complessa di Geriatria-Legnago-ULSS 9

intervention_type: Other


title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

summary:
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.

This is a randomized controlled, open clinical trial with two groups.

first group, 100 patients : control group, patients followed with no add-on intervention
Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.

ReferenceCitation: Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4.

ReferenceCitation: Rönning O. Alterations in craniofacial morphogenesis induced by parenterally administered papain. An experimental study on the rat. Suom Hammaslaak Toim. 1971;67:Suppl 3:3-96.

ReferenceCitation: Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9.

ReferenceCitation: Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

ReferenceCitation: Okubadejo AA, Paul EA, Jones PW, Wedzicha JA. Does long-term oxygen therapy affect quality of life in patients with chronic obstructive pulmonary disease and severe hypoxaemia? Eur Respir J. 1996 Nov;9(11):2335-9.

ReferenceCitation: Barnes PJ. Novel approaches and targets for treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 2):S72-9. Review.

ReferenceCitation: Hunter AM, Carey MA, Larsh HW. The nutritional status of patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1981 Oct;124(4):376-81.

ReferenceCitation: Schols AM, Soeters PB, Dingemans AM, Mostert R, Frantzen PJ, Wouters EF. Prevalence and characteristics of nutritional depletion in patients with stable COPD eligible for pulmonary rehabilitation. Am Rev Respir Dis. 1993 May;147(5):1151-6.

ReferenceCitation: Schols AM. Nutrition in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2000 Mar;6(2):110-5. Review.

ReferenceCitation: Schols AM, Mostert R, Soeters PB, Greve LH, Wouters EF. Nutritional state and exercise performance in patients with chronic obstructive lung disease. Thorax. 1989 Nov;44(11):937-41.

ReferenceType: derived

ReferenceCitation: Pison CM, Cano NJ, Chérion C, Caron F, Court-Fortune I, Antonini MT, Gonzalez-Bermejo J, Meziane L, Molano LC, Janssens JP, Costes F, Wuyam B, Similowski T, Melloni B, Hayot M, Augustin J, Tardif C, Lejeune H, Roth H, Pichard C; IRAD Investigators. Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial. Thorax. 2011 Nov;66(11):953-60. doi: 10.1136/thx.2010.154922. Epub 2011 Jun 23.

location_country: France Switzerland

location_facility: Departement of Medicine, University Hospital of Genève

location_facility: University Hospital Arnaud de Villeneuve

intervention_type: Behavioral


title: A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)

acronym: EMBRACE

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

ReferenceCitation: Ginzler E, Guedes Barbosa LS, D'Cruz D, Furie R, Maksimowicz-McKinnon K, Oates J, Santiago MB, Saxena A, Sheikh S, Bass DL, Burriss SW, Gilbride JA, Groark JG, Miller M, Pierce A, Roth DA, Ji B. Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2022 Jan;74(1):112-123. doi: 10.1002/art.41900. Epub 2021 Dec 9.

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3). pii: e001747. doi: 10.1136/rmdopen-2021-001747.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Brazil
United Kingdom
Colombia
France
United States
South Africa

intervention_type: Biological


title: Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial

acronym: COMFORT

summary:
The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.

Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.

lead_sponsor: Rennes University Hospital

location_country: Lebanon France

location_facility:
CH Pierre Oudot
Clinique Saint-Jean Cap Santé
CHU Toulouse - Hôpital Riquet
CHU Angers
CH Sud Francilien
APHP - Hôpital Cochin
CHRU Strasbourg - Hôpital Hautepierre
CHU Toulouse - Hôpital Rangueil
HIA Clermont Tonnerre
GHM de Grenoble
Centre Hospitalier Privé St Grégoire
CH Bourg en Bresse
Clinique du Parc
CH Dax
Chu Rennes - Pontchaillou
Clinique Juge
CH Bretagne Atlantique
APHP - Hôpital Bichat
Hôpital Hôtel Dieu de France
CHRU Lille - Hôpital Huriez
Clinique Jules Verne
Polyclinique Saint Laurent de Rennes
CH La Rochelle
CH Saint Joseph Saint Luc
CH Saint-Brieuc
Hôpital Foch
CHRU Tours - Hôpital Bretonneau
CHRU Amiens Picardie
Hôpital Privé Sévigné


title: A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable

acronym: PICASSO

summary: This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Hopital Des Diaconesses; Hopital De Jour

location_facility: Memorial France Etats Unis; Hopital De Jour

location_facility: Hopital De La Croix Rousse;Hepato Gastro Entero

location_facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

location_facility: Hopital De L Archet;Gastro Nutrition Oncologie

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Hopital Victor Jousselin; Gastro Enterologie

location_facility: Hopital Albert Michallon; Gastro Enterologie

location_facility: Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: CH Dptal Les Oudairies; Gastro Enterologie

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Clinique Chir De L Orangerie; Chimiotherapie

location_facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

location_facility: Hopital Yves Le Foll; Hepatologie Gastro Enterologie

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Hopital Alpha Sante De Hayange; Medecine B

location_facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Polyclinique Sainte Marguerite; Chimiotherapie

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Hopital Jacques Lacarin; Hopital De Jour

location_facility: Ch Lyon Sud; Gastro Secteur Jules Courmont

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: Hopital Simone Veil Eaubonne; Hopital De Jour

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Ch Jean Rougier; Oncologie Gastro Enterologie

location_facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Clinique Pasteur; Oncologie Medicale, Hematologie

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Ch De Montelimar; Gastro Enterologie Oncologie

location_facility: Centre Hospitalier General; Oncologie Medicale

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Hopital Charles Nicolle; Endoscopies Digestives

location_facility: Clinique Saint Faron; Sce Oncologie Radiotherapie

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne

location_facility: Clinique Du Parc Imperial; Chimiotherapie

location_facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour

location_facility: Infirmerie Protestante; Endos Digestive Coelioscopie

location_facility: Ctre Radiotherapie Joseph Belot; Hematologie

location_facility: Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie


acronym: EXCALIBER-RRMM

title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

lead_sponsor: Celgene

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

location_facility: New York - Presbyterian/Weill Cornell Medical Center

location_facility: Shengjing Hospital Of China Medical University

location_facility: Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences

location_facility: Centro Hospital e Universitario de Coimbra

location_facility: Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu

location_facility: Beijing Chaoyang Hospital Capital Medical University

location_facility: Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center

location_facility: Università di Catania- Presidio Ospedaliero Ferrarotto

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Uniwersytet Jagiellonski Collegium Medicum

location_facility: CHU de Nancy - Hopital Brabois- Service d'Hematologie et DE medecine Interne, 7eme etage

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Chang Gung Medical Foundation, Linkou Memorial Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Hospital Center of Lisbon North E.P.E - Hospital Pulido Valente

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Sahlgrenska University Hospital Department of Hematology and Coagulation

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: State Institution Hematological Research, Centre of Russian Academy of Medical Science

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Hwasun Chonnam National University Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Ipo Instituto Portugues De Oncologia Porto

location_facility: Kantonsspital St. GallenBereich OnkologieHamatologie

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Flinders Medical Centre, Dept Of Oncology

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Ondokuz Mayis University Medical Faculty

location_facility: Tennessee Oncology Nashville Drug Development Unit

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: West Penn Allegheny Lupus Center of Excellence

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Summit Medical Group Overlook Oncology Center

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Florida Cancer Specialists North Region Sarah Cannon Research

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Hospital Universitario Central de Asturias

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: Hospital Universitario Vall D hebron - PPDS

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

summary: This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).


type: Registry Identifier

title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

acronym: COMMANDS

summary: The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Sweden
Canada
Switzerland
Hungary
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Hospital Clinico Universitario de Valencia

location_facility: First Pavlov State Medical University of St. Petersburg

location_facility: Centre Hospitalier Universitaire de Sherbrooke CHUS

location_facility: Ipo Instituto Portugues De Oncologia Porto

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Karadeniz Technical University Medical Faculty

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hamatologie u. Onkologie

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Wojewodzki Szpital Specjalistyczny im Korczaka w Supsku

location_facility: Border Medical Oncology - Albury Wodonga Regional Cancer Centre

location_facility: Klinkum der Stadt Villingen-Schwenningen GmbH

location_facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat

location_facility: Seoul National University Bundang Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Western Kentucky Hematology and Oncology Group

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: National Hospital Organization - Nagoya Medical Center

location_facility: Hospital of Lithuanian University Health and Sciences

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Praxis fuer Haematologie und Onkologie Koblenz

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: Utah Cancer Specialists - South Salt Lake

location_facility: State Institution National Research Centre for Radiation Medicine of NAMS of Ukraine

location_facility: Alabama Oncology - Grandview Cancer Center

location_facility: National Association of Veterans Research and Education Foundations NAVREF

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center

location_facility: Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie

location_facility: Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec

location_facility: University General Hospital of Heraklion

location_facility: General Hospital of Athens - George Gennimatas

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Assistance Publique - Hopitaux de Paris - Hopitaux Saint-Louis

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Instituto Catalan de Oncologia-Hospital Duran i Reynals

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet


title: A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

acronym: apact

summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

ReferenceCitation: Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

ReferenceCitation: Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.

ReferenceCitation: Fernández A, Salgado M, García A, Buxò E, Vera R, Adeva J, Jiménez-Fonseca P, Quintero G, Llorca C, Cañabate M, López LJ, Muñoz A, Ramírez P, González P, López C, Reboredo M, Gallardo E, Sanchez-Cánovas M, Gallego J, Guillén C, Ruiz-Miravet N, Navarro-Pérez V, De la Cámara J, Alés-Díaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

ReferenceCitation: Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

ReferenceCitation: Reni M, Braverman J, Hendifar A, Li CP, Macarulla T, Oh DY, Riess H, Tempero M, Lu B, Marcus J, Joshi N, Botteman M, Dueck AC. Evaluation of Minimal Important Difference and Responder Definition in the EORTC QLQ-PAN26 Module for Assessing Health-Related Quality of Life in Patients with Surgically Resected Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Nov;28(12):7545-7554. doi: 10.1245/s10434-021-09816-z. Epub 2021 Apr 3.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Hong Kong
Portugal
Austria
Australia
Singapore
Canada
Hungary
Germany
Denmark
Taiwan
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: University of California, San Francisco Cutaneous Oncology and Melanoma Center

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Praxis Internistischer Onkologie und Hamatologie Frechen

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Praxis für Innere Medizin, Dr.Oettle Helmut

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Pole Des Specialites Medicales, Hopital Purpan

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Klinikum der Universitat Munchen-Grosshadern

location_facility: Memorial Sloan Kettering Cancer Center West Harrison

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Northshore University Healthsystem Research Institute

location_facility: University of Miami and Sylvester Cancer Center

location_facility: Rocky Mountain Cancer Centers, LLP [Denver-Midtown]

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Praxis Internistischer Onkologie und Hamatologie Koln

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy

location_facility: Hopital Edouard Herriot - Hepato-gastroenterologie

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

location_facility: State University of New York Upstate Medical Center

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: University of Wisconsin - Madison Cancer Center

location_facility: MSKCC at Mercy Medical Center Mercy RockvilleCenter

location_facility: Oregon Health and Science University OHSU

location_facility: Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie

location_facility: Centre Hospitalier de L'Universite de Montreal St-Luc

location_facility: MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow

location_facility: Hospital Clinico Universitario De Santiago De Compostela

location_facility: Prince of Wales Hospital the Chinese University of Hong Kong

location_facility: Karmanos Cancer Center Wayne State University

location_facility: Memorial Sloan-Kettering Cancer Center - NYC


title: Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

summary:
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Canada
Switzerland
Sweden
United States
France
Norway
Belgium
Japan
Germany

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette

location_facility: Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno

location_facility: Hematology and Oncology Associates of SC, LLC

location_facility: Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

location_facility: Hematology Oncology and clinical immunology / Heinrich-Heine-University

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: University of Rochester James P. Wilmot Cancer Center

location_facility: University of California San Diego Moores Cancer Center

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: The Leeds Teaching Hospitals NHS Trust - St James's University Hospital

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Norton Cancer Institute Louisville Oncology

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Tokyo Women's Medical University Hospital

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Winship Cancer Institute of Emory University

location_facility: Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)

location_facility: University of California, San Francisco- California

location_facility: Lombardi Cancer Center - Georgetown University Hospital

location_facility: Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: University of Pennsylvania Perelman Center for Advanced Medicine

location_facility: Weill Cornell Medicine / New York Presbyterian Hospital

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute University of South Florida

location_facility: Medizinische Klinik II ZIM,Hamatologie Onkologie Uniklinik Frankfurt

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Erasmus Medical Center - Daniel den Hoed

location_facility: NYU Langone Laura and Isaac Perlmutter Cancer Center

location_facility: Sidney Kimmel Comp Cancer Center at Johns Hopkins

intervention_type: Genetic


title: Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

summary: This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.

lead_sponsor: FibroGen

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Czechia
Poland
Argentina
Mexico
Brazil
Lebanon
Switzerland
Hungary
China
Germany
Denmark
Dominican Republic
Georgia
Ireland
Korea, Republic of
France
Colombia
Netherlands

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Instituto Nacional de Enfermedades Respiratorias INER

location_facility: Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

location_facility: HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit

location_facility: The First Hospital of Lanzhou University

location_facility: Inje University Hospital Iisan Paik Hospital

location_facility: The Catholic University of Korea, Seoul ST. Mary's Hospital

location_facility: Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: The Princess Alexandra Hospital NHS Trust

location_facility: Fundacion Respirar - Centro Médico Dra. De Salvo

location_facility: Municipal Institute for Lung Diseases and Tuberculosis

location_facility: American University of beirut medical center

location_facility: General Hospital of Tianjin Medical University

location_facility: Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP

location_facility: University of Wisconsin Clinical Research

location_facility: Beijing Frindship hosiptal capital Medical University

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Centro Medico de Enfermedades Respiratorias

location_facility: Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department

location_facility: General Hospital of Ningxia Medical University

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Unidad Medica para la Salud Integral (UMSI)

location_facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital

location_facility: TGH/USF Center for Advanced Lung Disease and Lung Transplant

location_facility: Centro de Investigacion Metabolica 'CINME'

location_facility: Agaplesion Evangelisches Krankenhaus Mittelhessen

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n

location_facility: Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG

location_facility: Research Institute Of Clinical Medicine Todua Clinic

location_facility: Manchester University NHS Foundation Trust

location_facility: Institut fur Pneumologie an der Universitat zu Koln

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

location_facility: Rafik Hariri University Hospital (Clinical Research Unit)

location_facility: Centre Memoire Ressources Recherche, Hopital F. MITTERRAND

location_facility: Longarts - Opleider Longziekten Zuyderland MC

location_facility: Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino

location_facility: Investigacion Biomedica Aplicada de Hidalgo

location_facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"

location_facility: St. Lucas Clinical Research Center SA de CV

location_facility: Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP

location_facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

location_facility: Studienkoordination Prüfstelle der GWT am Fachkrankenhaus Coswig GmbH

location_facility: Penn State Milton S Hershey Medical Center

location_facility: The First Hospital of China Medical University

location_facility: Miskolci Semmelweis Ignác Health Centre and Educational Clinic Nonprofit Ltd.

location_facility: Pulmonary Disease Specialists d/b/a PDS Research

location_facility: The Catholic University of Korea Bucheon St. Mary's Hospital

location_facility: Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours

location_facility: Seoul National University Bundang Hospital

location_facility: C.H.R.U. de Montpellier - Hôpital Lapeyronie

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: Semmelweis University Clinic of Pulmonology

location_facility: Hospital Universitario Nuestra Senora de Valme

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly

location_facility: BeiJing Chao-Yang Hospital,Capital Medical University

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: The General Hospital Corporation d/b/a Massachusetts General Hospital

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council

location_facility: Soonchunhyang University Hospital Bucheon

location_facility: Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil

location_facility: Nemocnice Na Bulovce, Klinika pneumologie

location_facility: The Second Xiangya Hospital of Central South University

location_facility: INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

location_facility: Oaxaca Site Management Organization S.C. (OSMO)

location_facility: Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez


title: Diagnostic Value of 18FDG PET/CT Textural Indices in Patients With an Adrenal Lesion

acronym: ImpactTexture

summary:
Tumors are characterized by a great heterogeneity. Characterizing this intra-tumor heterogeneity is a major challenge in oncology to improve the therapeutic management and move towards personalized medicine adapted to each patient. However, intra-tumor heterogeneity remains rarely used for diagnostic purposes The discovery of an adrenal mass can occur in different circumstances. Detection of an adrenal mass can be done in a context of secreting syndrome, in the assessment of an extra-adrenal neoplasia or fortuitously when performing an imaging for another reason. The etiologies are numerous (cortical tumors, medullary tumors, metastatic lesion of a extra-adrenal neoplasia, others). The adrenal masses can be divided into two categories, depending on whether they are hyperfunctional or not. In patients without an oncological history, an adrenal mass discovered is most often a benign adenoma, but requires an endocrine assessment. In patients with known primary cancer, approximately 30% of the adrenal masses are malignant.

In all cases, the diagnostic procedure includes an imaging assessment to characterize the lesion and an endocrine assessment. CT scan performed without and after intravenous iodinated contrast agent injection is the first-line examination to assess an adrenal mass.

18F-FDG-PET may be indicated as second-line for characterizing an adrenal mass. Adrenal tumor SUVmax (Standard Uptake Value) and adrenal tumor SUVmax / liver SUVmax ratio are routinely used to determine the malignancy of a lesion. Although very useful for assessing the glucose metabolism of a given lesion, these parameters do not allow assessing the heterogeneity of tumor uptake. The texture analysis corresponds to an analysis of the spatial distribution of FDG uptake, and allows, by the calculation of many indices, an evaluation of the heterogeneity of the tumors.

The hypothesis of our study is that the texture parameters could have an additional diagnostic value to improve the performance of conventional quantitative parameters to determine the malignancy of a lesion.

The objective of this study is to investigate the diagnostic value of texture indices in a large cohort of patients presenting an adrenal lesion

time_perspective: Retrospective


title: FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home

acronym: FRAGIL-IT

summary: The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.

lead_sponsor: University Hospital, Toulouse


title: Pain Coping Strategies in Children With Cerebral Palsy

summary: The aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy.

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

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


title: Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years

acronym: BALISTIC 2

summary:
The main objective of the BALISTIC research program is to characterize COPD related to organic particles (of which the model is agricultural COPD) in comparison with tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and physiopathological level.

The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and 2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic mechanisms.

The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of resting and exercise respiratory function parameters, its computed tomography presentation and its genetic and epigenetic profile.

The prospects of this work are to improve the management of COPD in any cause by setting up preventive and curative therapeutic approaches in order to provide answers to the progression of a disease that makes part of the few major public health problems of the 21st century.

status: Enrolling by invitation

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study

acronym: OESOCiTy

summary:
New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (SCC) in order to improve outcomes of this frequent and lethal cancer.

Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3D reconstruction. This device has never been tested on esophageal specimens.

Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in SCC.

To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device and we will compare the results with histological analysis of these specimens.

lead_sponsor: Nantes University Hospital


title: Phase I Trial of Carbonic Anhydrase Inhibition Associated With Platinum-based Chemotherapy and Etoposide in Concomitance With Radiotherapy in Localized Small Cell Lung Carcinomas

acronym: ICAR

summary:
The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy in localized small cell lung cancer due to:

The over-expression of carbonic anhydrases in this type of cancer,
The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines,
The observed synergy between irradiation and inhibition of carbonic anhydrases,
Potential anti-tumor immune effect caused by decreased extracellular acidity.

lead_sponsor: Centre Antoine Lacassagne


title: RTFM-AB - Repetitive Thinking in FibroMyalgia and Attentional Bias: Links Between Attentional Bias in Later Stages of Attention and Tendency to Repetitive Thinking

acronym: PRFM-BA

summary: Theoretical models of chronic pain hypothesize a privileged treatment of pain-related information that would be the basis of avoidance behaviors in chronic pain. This privileged treatment, also called attentional bias, has been found experimentally in chronic pain. Meta-analyses confirmed that but leaded the question of the difference found between bias in period of attention orientation and bias in period of maintained attention. One of the hypotheses is to consider one or more cognitive processes that would "fix" the attention around significant perceived problems and that would hinder the attentional disengagement and the reorientation of attention towards neutral or positive stimuli. In view of the scientific literature in psychopathology but also in chronic pain we think that the negative repetitive thoughts (RNT) variable is one of these processes. So the investigators want to better understand the difference of attentional bias at different moments of the attentional process by interrogating the Repetitive Thinking variable. More specifically the investigators test the Attentional Bias hypothesis in Fibromyalgia. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales and also the visual probe task. First, the investigators hypothesize the attention bias for pain-related information in the FM group is correlated with the level of negative repetitive thinking in the maintained attention phase. Second, the investigators hypothesize the attention bias is more important in the attention maintenance phase (1250 ms) than in the attention orientation phase (500 ms).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents

acronym: IDEFIX

summary: The aim of the present study is to compare the effect of two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. Investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.

ReferenceCitation: Roche J, Corgosinho FC, Dâmaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Túlio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates

acronym: BOOST-CA

summary: Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]

ReferenceType: result

ReferenceCitation: Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequéant B, Lartigau E. Low-dose-rate interstitial brachytherapy boost for the treatment of anal canal cancers. Brachytherapy. 2017 Jan - Feb;16(1):230-235. doi: 10.1016/j.brachy.2016.07.007. Epub 2016 Sep 3.

ReferenceCitation: Boukhelif W, Ferri-Molina M, Mazeron R, Maroun P, Duhamel-Oberlander AS, Dumas I, Martinetti F, Guemnie-Tafo A, Chargari C, Haie-Meder C. Interstitial pulsed-dose-rate brachytherapy for the treatment of squamous cell anal carcinoma: A retrospective single institution analysis. Brachytherapy. 2015 Jul-Aug;14(4):549-53. doi: 10.1016/j.brachy.2015.03.006. Epub 2015 Apr 29.

lead_sponsor: Institut Paoli-Calmettes


title: Prevalence of Ophthalmological Abnormalities in Children and Adults Suffering From Hereditary Ichthyosis

summary: Presence/absence of subclinical keratoconus with corneal topographic abnormalities (skewed radial axes for forme fruste keratoconus, and inferior steepening for keratoconus suspect) on axial specular topography (TMS-4 Tomey), and elevation topographies: Pentacam (Oculus) and Orbscan (Bausch & Lomb).


title: Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly

acronym: ANGIO SPIRUL

summary: The investigators hypothesize that spirulina-silicon supplementation will lead to an improvement in vasomotor endothelial function, followed by decreased arterial wave velocity on the aorta and central arterial pressure compared to placebo subjects.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Dietary Supplement


title: Work Package 4: HPV Vaccination of Women in Screening Ages

summary: The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

lead_sponsor: CHU de Reims