title: A Multidisciplinary Program for Preventing Falls "Identify, Prevent and Get up": Impact on Falls in Elderly Inpatients

acronym: IPR

summary: Falls among elderly inpatients are common, multifactorial and associated with a significant increase of complications and morbidity. According to a recent Cochrane review, the effectiveness of fall prevention program has been assessed in community-dwelling and in long stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study aims to measure the impact of a multidisciplinary prevention program on falls in elderly inpatients.

location_facility: Hospices Civils de Lyon - Service de Médecine gériatrique, Hôpital Edouard Herriot

location_facility: Hospices Civils de Lyon - Service de Gériatrie - Hôpital des Charpennes

location_facility: Hospices Civils de Lyon - Service de Médecine gériatrique, Centre Hospitalier Lyon-Sud

location_facility: Centre Hospitalier d'Ardèche Méridionale - Service de Gériatrie, Centre Hospitalier d'Ardèche Méridionale

location_facility: Hospices Civils de Lyon - Hôpital Frédérique Dugoujon

location_facility: Centre Hospitalier de Bourg en Bresse - Pôle filière gériatrique, Centre Hospitalier de Bourg en Bresse

location_facility: Centre Hospitalier d'Annecy - Pôle de Gériatrie - Centre Hospitalier d'Annecy

location_facility: Centre Hospitalier Lucien Hussel - Pôle gérontologie

location_facility: Hospices Civils de Lyon - Hôpital Pierre Garraud

location_facility: Centre Hospitalier Gériatrique du Mont d'Or

location_facility: Hospices Civils de Lyon - Hôpital Antoine Charial


title: An Open Label, Non-randomized, First-in-human, Multi-centre Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Locally Administered DT01 in Combination With Radiotherapy and Concomitant Dose of Chloroquine in Patients With Local Metastatic Melanoma With Relapsed Cutaneous/Subcutaneous Tumors Including Melanoma-in-transit

acronym: DRIIM

summary:
Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation.

DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.

The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: DNA Therapeutics

location_facility: Groupe Hospitalier Cochin - Hôtel Dieu-Broca

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial

summary:
Aim : Effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula.

Methods : French prospective multicenter randomized trial. Population study: Adult patients who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.

Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. With this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients.

Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula.

Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total duration of the study is 3 years and 3 months.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Maulat C, Regimbeau JM, Buc E, Boleslawski E, Belghiti J, Hardwigsen J, Vibert E, Delpero JR, Tournay E, Arnaud C, Suc B, Pessaux P, Muscari F. Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial. Br J Surg. 2020 Jun;107(7):824-831. doi: 10.1002/bjs.11405. Epub 2020 Jan 9.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility:
Institut Paoli Calmettes
CHU la conception
Hôpital Saint Antoine
hôpital Haute Pierre
CHU
Hotel Dieu
Toulouse Purpan
Hôpital Claude Huriez
Hôpital St Eloi
Hôpital beaujon
Hôpital Paul Brousse

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease

acronym: TAILORIX

summary: To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.

ReferenceType: background

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

ReferenceCitation: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85.

ReferenceCitation: Lémann M, Mary JY, Duclos B, Veyrac M, Dupas JL, Delchier JC, Laharie D, Moreau J, Cadiot G, Picon L, Bourreille A, Sobahni I, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial. Gastroenterology. 2006 Apr;130(4):1054-61.

ReferenceCitation: D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkühn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.

ReferenceCitation: Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, Stokkers P, Hommes D, Rutgeerts P, Vermeire S, D'Haens G; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology. 2010 Feb;138(2):463-8; quiz e10-1. doi: 10.1053/j.gastro.2009.09.056. Epub 2009 Oct 8.

ReferenceCitation: Louis E, Vernier-Massouille G, Grimaud JC, et al. Infliximab discontinuation in Crohn's disease patients in stable remission on combined therapy with immunosuppressors: a prospective ongoing cohort study. Gastroenterology 2009, 136:A-146

ReferenceCitation: Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

ReferenceCitation: Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. Epub 2006 Aug 22.

ReferenceCitation: Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010 Jan;59(1):49-54. doi: 10.1136/gut.2009.183095.

ReferenceCitation: Van Moerkercke W, Ackaert C, Compernolle G, Jürgens M, Cleynen I, Van Assche G, Rutgeerts P, Gils A, Vermeire S. High infliximab trough levels are associated with mucosal healing in Crohn's disease. Gastroenterology 2010; 138 (Supp 1), S-60.

ReferenceCitation: Louis E, Collard A, Oger AF, Degroote E, Aboul Nasr El Yafi FA, Belaiche J. Behaviour of Crohn's disease according to the Vienna classification: changing pattern over the course of the disease. Gut. 2001 Dec;49(6):777-82.

ReferenceCitation: Vermeire S, van Assche G, Rutgeerts P. Review article: Altering the natural history of Crohn's disease--evidence for and against current therapies. Aliment Pharmacol Ther. 2007 Jan 1;25(1):3-12. Review.

ReferenceCitation: Schnitzler F, Fidder H, Ferrante M, Noman M, Arijs I, Van Assche G, Hoffman I, Van Steen K, Vermeire S, Rutgeerts P. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflamm Bowel Dis. 2009 Sep;15(9):1295-301. doi: 10.1002/ibd.20927.

ReferenceCitation: D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34.

ReferenceCitation: Frøslie KF, Jahnsen J, Moum BA, Vatn MH; IBSEN Group. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology. 2007 Aug;133(2):412-22. Epub 2007 Jun 2.

ReferenceCitation: Rimola J, Rodriguez S, García-Bosch O, Ordás I, Ayala E, Aceituno M, Pellisé M, Ayuso C, Ricart E, Donoso L, Panés J. Magnetic resonance for assessment of disease activity and severity in ileocolonic Crohn's disease. Gut. 2009 Aug;58(8):1113-20. doi: 10.1136/gut.2008.167957. Epub 2009 Jan 9.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Chu Rennes
Chu Nancy
Hopital Beaujon
CHU NICE
CHU Bordeaux - Pessac
Chu Reims
Chu Tours
Chu Clermont-Ferrand
Hopital Saint Louis
Chu Toulouse
CHRU Lille


title: Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis

acronym: PREDICORT

summary: The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism: hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire de Toulouse

status_simplified: Unknown


title: A Multicentre, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis and Early Stage Acute Liver Failure

summary:
Acute liver failure is a rare but dramatic disease, often affecting young people, marked by the sudden loss of liver function in a person without preexisting liver disease.

ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this dramatic disease with high unmet medical need, a future therapy for the treatment of patients suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not due to acetaminophen overdose, where liver transplantation is the sole treatment in the absence of spontaneous recovery.

The primary objective of the study is to evaluate the efficacy of ALF-5755 versus placebo.

A minimum of 60 patients will be recruited into the study in the following two treatment groups:

Group A: approximately 30 patients will receive ALF-5755
Group B: approximately 30 patients will receive placebo (physiological saline solution: 0.9% NaCl)

Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in slow intravenous infusions over 10 minutes using automatic syringes.

ReferenceCitation: Christa L, Felin M, Morali O, Simon MT, Lasserre C, Brechot C, Sève AP. The human HIP gene, overexpressed in primary liver cancer encodes for a C-type carbohydrate binding protein with lactose binding activity. FEBS Lett. 1994 Jan 3;337(1):114-8.

ReferenceCitation: Hoofnagle JH, Carithers RL Jr, Shapiro C, Ascher N. Fulminant hepatic failure: summary of a workshop. Hepatology. 1995 Jan;21(1):240-52. Review.

ReferenceCitation: Iovanna JL, Dagorn JC. The multifunctional family of secreted proteins containing a C-type lectin-like domain linked to a short N-terminal peptide. Biochim Biophys Acta. 2005 May 25;1723(1-3):8-18. Epub 2005 Jan 21. Review.

ReferenceCitation: Kondo T, Suda T, Fukuyama H, Adachi M, Nagata S. Essential roles of the Fas ligand in the development of hepatitis. Nat Med. 1997 Apr;3(4):409-13.

ReferenceCitation: Lasserre C, Christa L, Simon MT, Vernier P, Bréchot C. A novel gene (HIP) activated in human primary liver cancer. Cancer Res. 1992 Sep 15;52(18):5089-95.

ReferenceCitation: Lieu HT, Batteux F, Simon MT, Cortes A, Nicco C, Zavala F, Pauloin A, Tralhao JG, Soubrane O, Weill B, Bréchot C, Christa L. HIP/PAP accelerates liver regeneration and protects against acetaminophen injury in mice. Hepatology. 2005 Sep;42(3):618-26.

ReferenceCitation: Lieu HT, Simon MT, Nguyen-Khoa T, Kebede M, Cortes A, Tebar L, Smith AJ, Bayne R, Hunt SP, Bréchot C, Christa L. Reg2 inactivation increases sensitivity to Fas hepatotoxicity and delays liver regeneration post-hepatectomy in mice. Hepatology. 2006 Dec;44(6):1452-64.

ReferenceCitation: Polson J, Lee WM; American Association for the Study of Liver Disease. AASLD position paper: the management of acute liver failure. Hepatology. 2005 May;41(5):1179-97.

ReferenceCitation: Simon MT, Pauloin A, Normand G, Lieu HT, Mouly H, Pivert G, Carnot F, Tralhao JG, Brechot C, Christa L. HIP/PAP stimulates liver regeneration after partial hepatectomy and combines mitogenic and anti-apoptotic functions through the PKA signaling pathway. FASEB J. 2003 Aug;17(11):1441-50.

ReferenceType: derived

ReferenceCitation: Nalpas B, Ichaï P, Jamot L, Carbonell N, Rudler M, Mathurin P, Durand F, Gerken G, Manns M, Trautwein C, Larrey D, Radenne S, Duvoux C, Leroy V, Bernuau J, Faivre J, Moniaux N, Bréchot C, Amouyal G, Amouyal P, Samuel D. A Proof of Concept, Phase II Randomized European Trial, on the Efficacy of ALF-5755, a Novel Extracellular Matrix-Targeted Antioxidant in Patients with Acute Liver Diseases. PLoS One. 2016 Mar 16;11(3):e0150733. doi: 10.1371/journal.pone.0150733. eCollection 2016.

lead_sponsor: Alfact Innovation

location_facility:
Centre Hépatobiliaire Paul Brousse
CHU Clermont-Ferrand
Hôpital Croix-Rousse
Hôpital Saint Antoine
Hôpital Conception
CHU de Grenoble
Hôpital Beaujon
Hôpital de l'Archet 2
Hôpital Claude Huriez
Hôpital La Pitié Salpétrière
Hôpital Saint-Eloi
CHU de Besançon


title: Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus

acronym: NNNB

summary:
Background and Rationale

Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.

Hypothesis

Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.

lead_sponsor: Association Pour la Recherche en Infectiologie

location_facility:
Edourad Herriot hospital
Frejus hospital
Nord Hospital
Ste MArguerite Hospital
Conception hospital
Pitie Salpetriere Hospital
St Louis Hospital
Cannes hosipital
CHU
Croix Rousse hospital
Hotel Dieu hospital
Hopital l'Archet 1


title: An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older

summary:
Primary objectives:

To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.

Secondary objectives:

•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)

•Secondary safety objective: To describe the safety profile after vaccination in each group

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: Germany France

intervention_type: Biological


title: A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy

summary: This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche


title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

summary: This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

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

location_facility:
CRLC Val d'Aurelle
Centre Paul Strauss
Institut Paoli Calmettes
Hopital Saint Eloi
Hopital Michallon
CAC Léon Bérard
Hotel Dieu
Centre Oscar Lambret
Institut Sainte catherine
Institut Gustave Roussy
Centre Rene Gauducheau
Hopital Saint Andre

intervention_type: Radiation


title: Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study

acronym: TVA

summary: The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".

ReferenceCitation: Nabholtz JM, Abrial C, Mouret-Reynier MA, Dauplat MM, Weber B, Gligorov J, Forest AM, Tredan O, Vanlemmens L, Petit T, Guiu S, Van Praagh I, Jouannaud C, Dubray-Longeras P, Tubiana-Mathieu N, Benmammar KE, Kullab S, Bahadoor MR, Radosevic-Robin N, Kwiatkowski F, Desrichard A, Cayre A, Uhrhammer N, Chalabi N, Chollet P, Penault-Llorca F. Multicentric neoadjuvant phase II study of panitumumab combined with an anthracycline/taxane-based chemotherapy in operable triple-negative breast cancer: identification of biologically defined signatures predicting treatment impact. Ann Oncol. 2014 Aug;25(8):1570-7. doi: 10.1093/annonc/mdu183. Epub 2014 May 14.

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Alexis Vautrin
Centre Georges François Leclerc
Centre Hospitalier
Institut Jean Godinot
Centre Paul Strauss
Centre Jean Perrin
Institut de Cancérologie de la Loire
Centre Léon Bérard
Centre Oscar Lambret
Hôpital Tenon
Pole Santé République
CHU Dupuytren


title: Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

summary: The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.

lead_sponsor: Sodilac

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)

intervention_type: Other


title: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

acronym: SENAT

summary:
This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.

The objectives of this study are:

Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
to evaluate adverse events.
Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Leung CH, Poon WS, Yu LM; International Subarachnoid Aneurysm Trial. The ISAT trial. Lancet. 2003 Feb 1;361(9355):430-1; author reply 432.

ReferenceCitation: Akpek S, Arat A, Morsi H, Klucznick RP, Strother CM, Mawad ME. Self-expandable stent-assisted coiling of wide-necked intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol. 2005 May;26(5):1223-31.

ReferenceCitation: Alfke K, Straube T, Dörner L, Mehdorn HM, Jansen O. Treatment of intracranial broad-neck aneurysms with a new self-expanding stent and coil embolization. AJNR Am J Neuroradiol. 2004 Apr;25(4):584-91.

ReferenceCitation: Baráth K, Cassot F, Rüfenacht DA, Fasel JH. Anatomically shaped internal carotid artery aneurysm in vitro model for flow analysis to evaluate stent effect. AJNR Am J Neuroradiol. 2004 Nov-Dec;25(10):1750-9.

ReferenceCitation: Benitez RP, Silva MT, Klem J, Veznedaroglu E, Rosenwasser RH. Endovascular occlusion of wide-necked aneurysms with a new intracranial microstent (Neuroform) and detachable coils. Neurosurgery. 2004 Jun;54(6):1359-67; discussion 1368.

ReferenceCitation: Byrne JV, Bashiri M, Pasco A, Morris JH. A novel flexible endovascular stent for use in small and tortuous vessels. Neuroradiology. 2000 Jan;42(1):56-61.

ReferenceCitation: Cantón G, Levy DI, Lasheras JC, Nelson PK. Flow changes caused by the sequential placement of stents across the neck of sidewall cerebral aneurysms. J Neurosurg. 2005 Nov;103(5):891-902.

ReferenceCitation: dos Santos Souza MP, Agid R, Willinsky RA, Cusimano M, Montanera W, Wallace MC, terBrugge KG, Marotta TR. Microstent-assisted coiling for wide-necked intracranial aneurysms. Can J Neurol Sci. 2005 Feb;32(1):71-81.

ReferenceCitation: Fiorella D, Albuquerque FC, Han P, McDougall CG. Preliminary experience using the Neuroform stent for the treatment of cerebral aneurysms. Neurosurgery. 2004 Jan;54(1):6-16; discussion 16-7.

ReferenceCitation: Howington JU, Hanel RA, Harrigan MR, Levy EI, Guterman LR, Hopkins LN. The Neuroform stent, the first microcatheter-delivered stent for use in the intracranial circulation. Neurosurgery. 2004 Jan;54(1):2-5.

ReferenceCitation: Lylyk P, Ferrario A, Pasbón B, Miranda C, Doroszuk G. Buenos Aires experience with the Neuroform self-expanding stent for the treatment of intracranial aneurysms. J Neurosurg. 2005 Feb;102(2):235-41.

ReferenceCitation: Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Viñuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66.

ReferenceCitation: Wakhloo AK, Lanzino G, Lieber BB, Hopkins LN. Stents for intracranial aneurysms: the beginning of a new endovascular era? Neurosurgery. 1998 Aug;43(2):377-9.

lead_sponsor: Stryker Neurovascular

location_facility:
Hôpital Saint-Roch
Fondation Rotschild
Hôpital Neurologique
Hôpital Gui de Chauliac
Centre Hospitalier pellegrin
CHU Nancy
CHU Limoges
Groupe Hospitalier Pitié-Salpétrière
CHU Hôpital de la Côte de Nacre
CHU Hôpital Guillaume et René Laënnec
CHRU Salengro
Hôpital Lariboisière

intervention_type: Device


title: Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.

acronym: TICE

summary:
Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis.

Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability.

This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.

study_start_date_type: Actual

ReferenceCitation: Chevreau C, Massard C, Flechon A, Delva R, Gravis G, Lotz JP, Bay JO, Gross-Goupil M, Fizazi K, Mourey L, Paci A, Guitton J, Thomas F, Lelièvre B, Ciccolini J, Moeung S, Gallois Y, Olivier P, Culine S, Filleron T, Chatelut E. Multicentric phase II trial of TI-CE high-dose chemotherapy with therapeutic drug monitoring of carboplatin in patients with relapsed advanced germ cell tumors. Cancer Med. 2021 Apr;10(7):2250-2258. doi: 10.1002/cam4.3687. Epub 2021 Mar 5.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Bergonié
Institut Paoli Calmette
Centre Antoine Lacassagne
Institut Val d'aurelle
Hopital St André
Hopital TENON
CHU
Centre Léon Bérard
Centre Paul Papin
Institut Gustave Roussy
Institut Claudius Regaud


title: Multicentre, Open Study for the Setting up of Population Pharmacokinetic Models and Bayesian Estimators for Individual Dose Adjustment of Immunosuppressive Drugs (Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Everolimus) During the First Year Post-grafting in Adult Heart Transplant Recipients.

acronym: PIGREC

summary:
The main objective is to develop pharmacokinetic methods for individual dose adjustment of the global immunosuppressive treatment (cyclosporine, tacrolimus, mycophenolate mofetil and everolimus, taking into account the pharmacokinetic interactions), in order to optimise the efficiency and reduce the potentially severe sides effects of these drugs.

Forty five heart-transplant patients are to be included in this phase IV study to obtain a minimum of 10 patients treated with tacrolimus-mycophenolate, 10 with cyclosporine-mycophenolate and 20 with everolimus-cyclosporine.

Ten to 11 blood samples will be collected within the 8 to 12 hours post-dose in each patient and the immunosuppressive drug concentrations will be measured by LC-MS/MS.

The pharmacokinetic models and Bayesian estimators thus developed will provide tools for individual dose adjustment of immunosuppressive drugs simultaneously, at different post-transplant periods, using the area under the concentration-time curve (AUC) estimated using a limited number of time-points (2 or 3).

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Rouen
CHU de NANCY
CHU de Nantes
Hôpital Européen Georges Pompidou
CHU de Clermont-Ferrand
CHU de Strasbourg
CHU de Bordeaux
Hôpital Pitié-Salpêtrière
CHU de Limoges
CHU de Lille
Hôpital Louis Pradel - CHU de Lyon
CHU de Rennes


title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects

acronym: MAPT

summary:
Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
To study the long-term safety and tolerability of V0137,
To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)

ReferenceCitation: Pagès A, Costa N, Mounié M, Cestac P, De Souto Barreto P, Rolland Y, Vellas B, Molinier L, Juillard-Condat B; MAPT/DSA Group. Healthcare Costs Associated with Potentially Inappropriate Medication Prescribing Detected by Computer Algorithm Among Older Patients. Drugs Aging. 2022 May;39(5):367-375. doi: 10.1007/s40266-022-00938-x. Epub 2022 May 24.

ReferenceCitation: Rouch L, Rolland Y, Hanon O, Vidal JS, Cestac P, Sallerin B, Andrieu S, Vellas B, Barreto PS; MAPT/DSA Group. Blood pressure, antihypertensive drugs, and incident frailty: The Multidomain Alzheimer Preventive Trial (MAPT). Maturitas. 2022 Aug;162:8-14. doi: 10.1016/j.maturitas.2022.03.001. Epub 2022 Mar 15.

ReferenceCitation: Pagès A, Costa N, González-Bautista E, Mounié M, Juillard-Condat B, Molinier L, Cestac P, Rolland Y, Vellas B, De Souto Barreto P; MAPT/DSA Group. Screening for deficits on intrinsic capacity domains and associated healthcare costs. Arch Gerontol Geriatr. 2022 May-Jun;100:104654. doi: 10.1016/j.archger.2022.104654. Epub 2022 Feb 7.

ReferenceCitation: Raffin J, Angioni D, Giudici KV, Valet P, Aggarwal G, Nguyen AD, Morley JE, Guyonnet S, Rolland Y, Vellas B, de Souto Barreto P; MAPT/DSA Group. Physical Activity, Body Mass Index, and Blood Progranulin in Older Adults: Cross-Sectional Associations in the MAPT Study. J Gerontol A Biol Sci Med Sci. 2022 Jun 1;77(6):1141-1149. doi: 10.1093/gerona/glac018.

ReferenceCitation: Giudici KV, Guyonnet S, Morley JE, Nguyen AD, Aggarwal G, Parini A, Li Y, Bateman RJ, Vellas B, de Souto Barreto P; MAPT/DSA Group. Interactions Between Weight Loss and Plasma Neurodegenerative Markers for Determining Cognitive Decline Among Community-Dwelling Older Adults. J Gerontol A Biol Sci Med Sci. 2022 Jun 1;77(6):1159-1168. doi: 10.1093/gerona/glac015.

ReferenceCitation: Lu WH, Giudici KV, Rolland Y, Guyonnet S, Mangin JF, Vellas B, de Souto Barreto P. Associations Between Nutritional Deficits and Physical Performance in Community-Dwelling Older Adults. Front Nutr. 2021 Nov 11;8:771470. doi: 10.3389/fnut.2021.771470. eCollection 2021.

ReferenceCitation: Raffin J, Rolland Y, He L, Perus L, Mangin JF, Gabelle A, Virecoulon Giudici K, Vellas B, de Souto Barreto P; MAPT/DSA Group. Cross-sectional and longitudinal interaction effects of physical activity and APOE-ε4 on white matter integrity in older adults: The MAPT study. Maturitas. 2021 Oct;152:10-19. doi: 10.1016/j.maturitas.2021.06.010. Epub 2021 Jun 30.

ReferenceCitation: Costa N, Mounie M, Pages A, Derumeaux H, Rapp T, Guyonnet S, Coley N, Cantet C, Carrie I, Andrieu S, Molinier L. The Cost-Effectiveness of Three Prevention Strategies in Alzheimer's Disease: Results from the Multidomain Alzheimer Preventive Trial (MAPT). J Prev Alzheimers Dis. 2021;8(4):425-435. doi: 10.14283/jpad.2021.47.

ReferenceCitation: Coley N, Coniasse-Brioude D, Igier V, Fournier T, Poulain JP, Andrieu S; ACCEPT study group. Disparities in the participation and adherence of older adults in lifestyle-based multidomain dementia prevention and the motivational role of perceived disease risk and intervention benefits: an observational ancillary study to a randomised controlled trial. Alzheimers Res Ther. 2021 Sep 24;13(1):157. doi: 10.1186/s13195-021-00904-6.

ReferenceCitation: Conejero I, Dubois J, Gutierrez LA, Delrieu J, Arbus C, Garcia M, Lopez-Castroman J, Courtet P, Gabelle A. Amyloid Burden and Depressive Symptom Trajectories in Older Adults at Risk of Developing Cognitive Decline. J Clin Psychiatry. 2021 Aug 3;82(5). pii: 20m13410. doi: 10.4088/JCP.20m13410.

ReferenceCitation: González-Bautista E, de Souto Barreto P, Andrieu S, Rolland Y, Vellas B; MAPT/DSA group (members are listed under 'Contributors'). Screening for intrinsic capacity impairments as markers of increased risk of frailty and disability in the context of integrated care for older people: Secondary analysis of MAPT. Maturitas. 2021 Aug;150:1-6. doi: 10.1016/j.maturitas.2021.05.011. Epub 2021 Jun 4.

ReferenceCitation: He L, de Souto Barreto P, Aggarwal G, Nguyen AD, Morley JE, Li Y, Bateman RJ, Vellas B; MAPT/DSA Group. Plasma Aβ and neurofilament light chain are associated with cognitive and physical function decline in non-dementia older adults. Alzheimers Res Ther. 2020 Oct 8;12(1):128. doi: 10.1186/s13195-020-00697-0.

ReferenceCitation: Gallini A, Yrondi A, Cantet C, Poncet M, Vellas B, Schmitt L, Andrieu S. Red Blood Cell Omega-3 Fatty Acid Composition and Psychotropic Drug Use in Older Adults: Results from the MAPT Study. J Nutr Health Aging. 2019;23(9):805-812. doi: 10.1007/s12603-019-1252-4.

ReferenceCitation: Guerville F, de Souto Barreto P, Taton B, Bourdel-Marchasson I, Rolland Y, Vellas B; Multidomain Alzheimer Preventive Trial (MAPT)/Data Sharing Alzheimer (DSA) Group. Estimated Glomerular Filtration Rate Decline and Incident Frailty in Older Adults. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1597-1604. doi: 10.2215/CJN.03750319. Epub 2019 Oct 18.

ReferenceCitation: Gabelle A, Gutierrez LA, Jaussent I, Navucet S, Grasselli C, Bennys K, Marelli C, David R, Andrieu S, Berr C, Vellas B, Dauvilliers Y. Excessive Sleepiness and Longer Nighttime in Bed Increase the Risk of Cognitive Decline in Frail Elderly Subjects: The MAPT-Sleep Study. Front Aging Neurosci. 2017 Sep 28;9:312. doi: 10.3389/fnagi.2017.00312. eCollection 2017.

ReferenceCitation: Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, Desclaux F, Gabelle A, Gasnier Y, Pesce A, Sudres K, Touchon J, Robert P, Rouaud O, Legrand P, Payoux P, Caubere JP, Weiner M, Carrié I, Ousset PJ, Vellas B; MAPT Study Group. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27.

ReferenceCitation: Gillette-Guyonnet S, Andrieu S, Dantoine T, Dartigues JF, Touchon J, Vellas B; MAPT Study Group. Commentary on "A roadmap for the prevention of dementia II. Leon Thal Symposium 2008." The Multidomain Alzheimer Preventive Trial (MAPT): a new approach to the prevention of Alzheimer's disease. Alzheimers Dement. 2009 Mar;5(2):114-21. doi: 10.1016/j.jalz.2009.01.008.

location_country: France Monaco

location_facility:
University Hospital of Nice
UH of LYON SUD
University Hospital Toulouse
University Hospital Montpellier
Princesse Grace Hospital
Chg Montauban
University Hospital Limoges
University Hospital Bordeaux
Regional Hospital
University Hospital of Dijon

intervention_type: Dietary Supplement


title: Clinical Evaluation on Advanced Resynchronization

summary:
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.

PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.

lead_sponsor: LivaNova

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany

location_facility:
Osp. Civile
CH Pau
Medisch Centrum Rijnmond-Zuid
CHU Angers
CHU Bordeaux
Vlietland Ziekenhuis
Hosp. Clinico
Univ Saarland
InParys Cardiology
Osp. S. Maria Nuova
H. Virgen de las Nieves
Royal Hospital
Isala Klinieken
UKB Unfallkrankenhaus
CHR Cardiologie A
Stiftsklinikum Augustinum
H. General Universit.
Diaconessenhuis
Osp. Univ. Careggi
University Hospital
Osp. Niguarda
CHU Poitiers
CHU Rouen
Saint Peter's Hospital
Osp. S. Filippo Neri
Nothern General
CH Lomme
General Hospital
NC Nantaises
CH Yves le Foll
CHU Montpellier
St.Adolfstift
CH Albi
Osp. B. Ramazzini


title: A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Combination With Melphalan and Dexamethasone in Subjects With Newly-diagnosed Light-chain (AL)-Amyloidosis

summary: Amyloidosis results from tissue deposition of amyloid protein, composed mainly by the fragments of monoclonal immunoglobulin heavy chains or light chains. Accumulation of amyloid protein progressively disrupts normal tissue structure and ultimately leads to organ failure, most frequently in the kidneys, heart, liver and peripheral nervous system. A recently completed French prospective randomized trial, in patients presenting with newly AL-amyloidosis, compared two treatment regimens at the time of diagnosis: Melphalan-dexamethasone (conventional oral treatment), versus high dose of Melphalan followed by autologous stem cell transplantation (ASCT) (1). High-dose therapy was not associated with a better outcome. Melphalan-dex given monthly can be considered as the current standard of care, with a median survival of 56 months. The use of a combination of lenalidomide and dexamethasone has already been tested in patients with AL-amyloidosis (2). The initial dose of lenalidomide at 25 mg/day was poorly tolerated. However, a 15 mg/day dose regimen was well tolerated and effective, with an overall hematologic response rate of 67%. Hematologic responses were associated with clinical responses. Dispenzieri et al confirmed that the combination of Lenalidomide + dexamethasone achieved a 75% hematologic response rate, with a 42% organ response, and a median follow-up of 17 months in patients still receiving treatment (2006). These authors also recommended a lower dose of 15mg/day. The rationale for the present investigation is that addition of lenalidomide to the current standard of care (Melphalan-dexamethasone) might improve the hematologic response rate and the organ response rates both associated with a prolonged survival in patients with AL-amyloidosis. As the toxicity of the combination of M-dex + lenalidomide is unknown in patients with AL-amyloidosis, the dose of lenalidomide will start from the lowest one available, i.e., 5 mg/day and increased from 5 to 5 mg up to a maximum dose of 15 mg in combination with M-dex in 3 consecutive cohorts of patients, according to toxicity. When the optimal dose of lenalidomide will be defined, 9 additional patients will be included in the trial at the recommended dose-level to assess the feasibility of the combination M-dex-lenalidomide.

ReferenceCitation: Moreau P, Jaccard A, Benboubker L, Royer B, Leleu X, Bridoux F, Salles G, Leblond V, Roussel M, Alakl M, Hermine O, Planche L, Harousseau JL, Fermand JP. Lenalidomide in combination with melphalan and dexamethasone in patients with newly diagnosed AL amyloidosis: a multicenter phase 1/2 dose-escalation study. Blood. 2010 Dec 2;116(23):4777-82. doi: 10.1182/blood-2010-07-294405. Epub 2010 Aug 19.

lead_sponsor: Nantes University Hospital

location_facility:
Hôpitaux Civils de Lyon
CHU de Nantes
CHRU d'Amiens
Hôpital Saint-Louis
CHU de Poitiers
Hôpital necker
CHRU deTours
CHU de Toulouse
Hôpital Pitié Salpetrière
CHU de Limoges
CHRU de Lille
CHU de Rennes


type: Other Identifier

title: Randomized Study With Medico-economic Evaluation Comparing the Use of PTFE Covered Stents vs Naked Stent in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

summary:
Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.

The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.

The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.

Population concerned: Patients with a cirrhotic portal hypertension responsible for:

recurrent variceal bleeding
refractory ascite (or hydrothorax)

ReferenceCitation: Perarnau JM, Noeldge G, Rössle M. [Intrahepatic portacaval anastomosis by the transjugular approach. Use of the Palmaz endoprosthesis]. Presse Med. 1991 Nov 9;20(36):1770-2. French.

ReferenceCitation: Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Péron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75.

ReferenceCitation: Nishimine K, Saxon RR, Kichikawa K, Mendel-Hartvig J, Timmermans HA, Shim HJ, Uchida BT, Barton RE, Keller FS, Rösch J. Improved transjugular intrahepatic portosystemic shunt patency with PTFE-covered stent-grafts: experimental results in swine. Radiology. 1995 Aug;196(2):341-7.

ReferenceCitation: Angermayr B, Cejna M, Koenig F, Karnel F, Hackl F, Gangl A, Peck-Radosavljevic M; Vienna TIPS Study Group. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology. 2003 Oct;38(4):1043-50.

ReferenceCitation: Charon JP, Alaeddin FH, Pimpalwar SA, Fay DM, Olliff SP, Jackson RW, Edwards RD, Robertson IR, Rose JD, Moss JG. Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. J Vasc Interv Radiol. 2004 Nov;15(11):1219-30.

ReferenceCitation: Barrio J, Ripoll C, Bañares R, Echenagusia A, Catalina MV, Camúñez F, Simó G, Santos L. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. Eur J Radiol. 2005 Jul;55(1):120-4.

ReferenceCitation: Vignali C, Bargellini I, Grosso M, Passalacqua G, Maglione F, Pedrazzini F, Filauri P, Niola R, Cioni R, Petruzzi P. TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. AJR Am J Roentgenol. 2005 Aug;185(2):472-80.

ReferenceCitation: Rössle M, Siegerstetter V, Euringer W, Olschewski M, Kromeier J, Kurz K, Langer M. The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients. Acta Radiol. 2006 Sep;47(7):660-6.

ReferenceCitation: Gandini R, Konda D, Simonetti G. Transjugular intrahepatic portosystemic shunt patency and clinical outcome in patients with Budd-Chiari syndrome: covered versus uncovered stents. Radiology. 2006 Oct;241(1):298-305. Epub 2006 Aug 14.

ReferenceCitation: Tripathi D, Redhead D. Transjugular intrahepatic portosystemic stent-shunt: technical factors and new developments. Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1127-33. Review.

ReferenceCitation: Riggio O, Angeloni S, Nicolao F, Ridola L, Salvatori FM et al. Hepatic Encephalopathy is more frequent and severe after Transjugular intrahepatic portosystemeic Shunt (TIPS) with PTFE-coveted stent-grafts. Hepatology 2006;44, suppl 1, 232

lead_sponsor: University Hospital, Tours

location_facility: CHRU NANTES / Hôpital Guillaume et René Laënnec


title: A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease

lead_sponsor: Pfizer

type: EudraCT Number

source: euctr

ReferenceCitation: Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.

location_country: Germany France Spain

location_facility: Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Technische Universitaet Muenchen, Klinikum rechts der Isar

location_facility: Hospital Universitario Clinico San Carlos

summary: To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.


title: Effect of Strict Glycemic Control on Improvement of Exercise Capacities (VO2 Peak, Peak Workload After Cardiac Rehabilitation, in Patients With Type 2 Diabetes Mellitus With Coronary Artery Disease.

summary: The aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.

ReferenceCitation: Vergès B, Patois-Vergès B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: centre de réadaptation cardiaque "Château le moine"

location_facility: Rééducation cardiovasculaire CRF Kerpape


title: Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

summary: As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

ReferenceCitation: Gillet Y, Steri GC, Behre U, Arsène JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Germany France Italy


title: Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.

summary: The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.

ReferenceCitation: Evrard S, Rivoire M, Arnaud J-, Lermite E, Bellera C, Fonck M, Becouarn Y, Lalet C, Puildo M, Mathoulin-Pelissier S. Unresectable colorectal cancer liver metastases treated by intraoperative radiofrequency ablation with or without resection. Br J Surg. 2012 Apr;99(4):558-65. doi: 10.1002/bjs.8724.

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre de Radiothérapie et d'Oncologie Médicale


title: Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old. Cefixime PO 10d vs Ceftriaxone IV 4d Followed by Cefixime PO 6d. Multicenter, Randomised Trial of Equivalence.

summary:
The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.

The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.

ReferenceCitation: Sannier N, Le Masne A, Sayegh N, Gaillard JL, Chéron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3.

ReferenceCitation: Leroy S, Marc E, Adamsbaum C, Gendrel D, Bréart G, Chalumeau M. Prediction of vesicoureteral reflux after a first febrile urinary tract infection in children: validation of a clinical decision rule. Arch Dis Child. 2006 Mar;91(3):241-4. Epub 2005 May 12.

ReferenceCitation: Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Bréart G, Chalumeau M. Procalcitonin as a predictor of vesicoureteral reflux in children with a first febrile urinary tract infection. Pediatrics. 2005 Jun;115(6):e706-9. Epub 2005 May 2.

ReferenceCitation: Marc E, Ménager C, Moulin F, Stos B, Chalumeau M, Guérin S, Lebon P, Brunet F, Raymond J, Gendrel D. [Procalcitonin and viral meningitis: reduction of unnecessary antibiotics by measurement during an outbreak]. Arch Pediatr. 2002 Apr;9(4):358-64. French.

ReferenceCitation: Bocquet N, Sergent Alaoui A, Jais JP, Gajdos V, Guigonis V, Lacour B, Chéron G. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children. Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Antoine Beclere
Chu de Limoges
Hôpital Ambroise Pare
Hopital Pellegrin
CHU NICE
Hôpital Armand Trousseau
Hopital Andre Mignot
Saint Vincent de Paul
Hopital de Bicetre
Necker Enfants Malades
Robert Debre
La Timone


title: Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma.

ReferenceCitation: Dupuis O, Vie B, Lledo G, Hennequin C, Noirclerc M, Bennamoun M, Jacob JH. Preoperative treatment combining capecitabine with radiation therapy in rectal cancer: a GERCOR Phase II Study. Oncology. 2007;73(3-4):169-76. doi: 10.1159/000127383. Epub 2008 Apr 16.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hopital Saint - Louis
Hopital Drevon
Hopital Saint-Louis
Clinique Saint Jean
Centre Medico-Chirurgical Foch
Centre Jean Bernard
C.H. Senlis
Centre Hospitalier de Mulhouse
Centre Regional Francois Baclesse
Hopital Tenon
Hopital Notre-Dame de Bon Secours
Intercommunal Hospital


title: Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron


title: Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis

acronym: CAR-CF

summary: Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed

status: Recruiting

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de pédiatrie générale et spécialisée American Memorial Hospital - CHU de Reims

location_facility: Pneumologie, allergologie et Mucoviscidose - CRCM Lyon pédiatrie Hôpital Femme Mère Enfant /Groupement Est

location_facility: Maladies respiratoires, allergologie - CRCM Mixte de Rouen Hôpital Charles Nicole - CHU de Rouen

location_facility: CRCM Pédiatrique Hôpital Sud - CHU de Rennes

location_facility: Service Pneumologie-Allergologie CRCM adulte Hôpital Larrey - CHU de Toulouse

location_facility: Service de pneumologie - Centre cardio-pneumologie Hôpital Pontchaillou - CHU de Rennes

location_facility: Service de pneumo-allergologie pédiatrique CRCM pédiatrique CHU de Toulouse - Hôpital des Enfants

location_facility: C.R.C.M. Pédiatrique (Centre de Ressources et de Compétences en Mucoviscidose) Hôpital des Enfants-Pellegrin - CHU de Bordeaux

location_facility: Service des maladies respiratoires Hôpital Arnaud de Villeneuve - CHU de Montpellier

location_facility: Centre de Ressources et de Competences de la Mucoviscidose (Enfants) CHU Grenoble Alpes - Hôpital Couple Enfant

status_simplified: Ongoing


title: Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment

summary: To evaluate, over a period of six months, the links between physiological data collected such as electrodermal activity (or Galvanic Skin Response), motor activity measured by accelerometer, heartbeat measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.

primary_purpose: Supportive Care

lead_sponsor: Digital For Mental Health

location_facility:
APPT 22 Residence les Tilleuls
22 rue Jacques Boutrolles
203 rue de la Motte
Clinique Lyon Lumiere
19 rue de la Liberté
119 rue de la Pompe
2 boulevard Winston Churchill
145 avenue des Minimes
135 rue Nestor Longue Epee
91 rue Caulaincpurt

intervention_type: Behavioral


title: NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

acronym: NABAb

summary:
Behavioural addictions (BAs) [gambling disorder (GD), food addiction (FA), sexual addiction (SA)] may lead to disastrous consequences. They are often associated with other addictive or psychiatric disorders, and high rates of suicide attempts. Epidemiological studies report prevalence reaching 2.7% for GD, 5% for SA, and up to 7.9% for FA.

Many similarities have been highlighted between BAs, as well as with substance use disorders. One core clinical similarity between those disorders is craving (uncontrollable urge to engage in rewarding behaviours), which has been consistently associated with diminished control over the behaviour and relapse.

At present, no pharmacological treatment has been approved for BAs, but several medications have been tested. Among them, two opioid receptor antagonists - naltrexone and nalmefene - appear the most promising. By decreasing dopamine neurotransmission in the reward circuitry, they reduce both excitement for rewarding behaviours and craving.

Compared to naltrexone, nalmefene seems to have a better safety. To date, no study investigated the efficacy of nalmefene as a pan-addiction treatment for BAs. Two clinical trials have demonstrated its efficacy for the treatment of GD, but no clinical trial was conducted for FA and SA.

The investigators hypothesise that nalmefene (36 mg/d), compared to a placebo, can have a therapeutic effect as an add-on to usual treatment for decreasing craving in several BAs.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Undecided

location_facility:
CH de La Rochelle
CHU de Nantes
CHU de Clermont Ferrand
CHRU de Brest
CHU de Bordeaux
CHU de Nîmes
CHRU de Tours
Hospices Civils de Lyon
CHRU de Lille
Hôpitaux Universitaires de Strasbourg
Hôpital Paul Brousse


title: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study

acronym: TERTIO

summary: The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre Georges François Leclerc
Hôpital Nord Franche-Comté
Groupe Hospitalier Paris Salpetrière
Institut Mutualiste Montsouris
CHU de Grenoble
Centre Léon Bérard
Hôpital BEAUJON
CHU de Montpellier
Centre Hospitalier Paris St Joseph
Hôpital Henri Mondor
CHU de Besançon


title: Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)

acronym: ANCAPRO

summary:
The main objective is to identify specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified by questioning, geographical distribution of cases) from the RNV3P data.

The secondary objectives are as follows:

Description of cases of ANCA vasculitis seen in French occupational pathology consultation centres:

reasons for consultation,
occupational and environmental etiologies described
occupational situations responsible
aptitude notices
recognition as an occupational disease
Identification of specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified on questioning, geographical distribution of cases).
For occupational and non-occupational cases of ANCA vasculitis: identification of difficulties encountered by patients at work and proposed work adaptations.
Estimation of the number of applications for recognition of disabled worker status made within this patient group.
Identification of clinical severity and autoimmune profiles of ANCA vasculitis of occupational and/or environmental origin.

time_perspective: Retrospective

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
HCL
CHU de LILLE
CHU de Nantes
CHU de Grenoble
CHU de Strasbourg
Hôpital Cochin ( AP-HP)
CHU de Toulouse
CHU de Bordeaux
AP-HM
CHU de Nancy
CHU de Rennes


title: Aging With HIV and Neurocognitive Decline, a Follow-up Study

acronym: AgingHAND

summary:
The ANRS ( Agence Nationale de Recherches sur le Sida et les Hépatites virales) 0093s Aging HAND study is to assess whether PLHIV (People Living with HIV) initially between 55-70 years of age at baseline analysis under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up.

Aging HAND is a French, multicentric, longitudinal, transversal, prospective study with inclusion of 290 PLHIV.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
CHU Nantes
Hôpital Pellegrin
CHU Grenoble Alpes
Hôpital Carémeau, CHU Nîmes
Hopital Pitié Salpêtrière
CHU Montpellier
Hôpital Saint André
Hôpital Bretonneau, CHU Tours
CH Cannes
CHD Vendée
Hôpital Sainte Marguerite


title: Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid

acronym: IGA score

summary: The aim of the study is to validate a global and simple score : IGA (Investigator Global Assessment) score for the evaluation of the extent and severity of the disease in patients with bullous pemphigoid

lead_sponsor: University Hospital, Rouen

location_facility:
Lille University Hospital
Dijon University Hospital
Montpellier University Hospital
Reims University Hospital
Henri Mondor Hospital
Bichat Hospital
Avicennes Hospital
Saint-Louis Hospital
Bordeaux University Hospital
Lyon University Hospital
Nantes University Hospital


title: A Randomized Crossover Pragmatic Study to Evaluate Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Patients With Spinal Muscular Atrophy. REALITY Study.

acronym: REALITY

summary: The primary objective of the study is to evaluate anxiety level during intrathecal administration (IT) under standard of care (SOC) and virtual reality (VR) conditions using a reliable self-rating scale.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_facility:
Research Site
Research SIte


acronym: FECES

title: Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

location_facility:
Bicêtre Hospital
Saint Louis Hospital
Lariboisière Hospital
Henri Mondor Hospital
La Pitié Salpêtrière Hospital
Tenon Hospital
Bichat Hospital
Beaujon Hospital
Saint Antoine Hospital
Raymond Poincaré Hospital

summary: Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.


title: Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia

acronym: ARTOME

summary:
Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.

Adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.

ARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.

ARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.

lead_sponsor: Center Eugene Marquis

location_facility:
CRLCC Antoine Lacassagne
Clinique Pasteur Lanroze
Centre Paul Strauss
CRLCC Oscar Lambret
CHU de la Milétrie
Centre Eugene Marquis
CRLCC Henri Becquerel
Centre Léon Bérard
CRLCC Baclesse
Clinique Claude Bernard
CHU Tours - Hôpital Bretonneau


title: A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine

summary: The purpose of this study is to assess the incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain due to fluoropyrimidines in the adjuvant or metastatic setting .

location_facility:
CHU Tours Hôpital Trousseau
Chu Dijon
Centre Hospitalier Boulogne/ Mer
CHU Jean Minjoz
Hôpital Saint Antoine
CHU Poitiers
CHU Pontchaillou
Hôpital Privé Jean Mermoz
Hôpital Robert Debré
Hôptial Henri Mondor
GH Pitié Salpêtrière


title: Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis

acronym: Quali-SAT

summary: Patients in maintenance treatment for HFE hemochromatosis since at least one year will be included in a two year study period and randomized in two groups experimental and control group. Because proton pump inhibitors are widely used as chronic medication, and because they can significantly modify iron absorption, patients will be stratified according to the use of proton pump inhibitors and gender. A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients. Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group (patients treated with bloodletting according to current guidelines "ferritin alone" versus patients treated with bloodletting according to "transferrin saturation and serum ferritin").Blood count and iron metabolism parameters will be performed at each bloodletting and follow-up visits. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit. Volume and schedule for bloodlettings will be determined according to guidelines specifically designed for this study to assure harmonization of treatment management, and centrally validated through the recording of the biological tests in the electronic Case Report Form which will provide the investigator with the volume and schedule of the next bloodletting. There will be two ways of treatment modification: either change of schedule or volume of bloodletting. Patients will undergo follow-up visit every six months with clinical examination, questionnaires at J0, M12 and M24 (SF-36; AIMS2-SF, WOMAC, EQ-5D-5L), and biological test. For health economics analysis, data will be obtained thanks to a dedicated extraction from SNDS database SNDS database will allow to gather hospital stays, visits, and other healthcare-related costs as well as vital status (date (month/year) of death) and cause of death. A de-identified copy of the clinical database, restricted to the relevant variables, will be sent for semideterministic matching purpose with SNDS extraction using four key variables: gender, same date (month/year) of birth, same date (day/month/year) of visit for bloodletting; pending, of course, regulatory authorization.

lead_sponsor: Rennes University Hospital

location_facility:
CH de St Malo
Hôpital Rangueil
CHR Orléans
Centre hospitalier Bretagne Atlantique
CH Yves le Foll
Hopital Avicenne
CHU Rennes
GHRMSA - Hôpital Emile Muller
CHU Dupuytren
GHBS site du Scorff
Hôpital Paul Brousse


title: Performance of Prostate MRI and Targeted Biopsy to Detect Residual Prostate Cancer Following Focal Therapy

acronym: IRMProft

summary:
The management of localized prostate cancer remains controversial because of a risk of over diagnosis and over treatment. Focal therapy represents an approach to improve the therapeutic ratio of prostate cancer treatments. Focal therapy has been developed as minimally invasive procedure with the aim of providing equivalent oncological safety, reduced toxicity and improved functional outcomes. Multiparametric (mp) MRI Imaging may provide a reliable mean of monitoring for disease recurrence, and has been suggested as the most accurate imaging tool currently available for systematic detection of recurrence, pre-biopsy and preoperative mapping for an eventual salvage therapy. However, question about the performance of MRI and targeted biopsy in monitoring and defining successful therapy and follow up has been poorly evaluated. Modalities (standard biopsy, ablation zone biopsy vs targeted biopsy) and number of biopsies to be performed, depending on the results of MRI, remains unanswered due to a lack of available data.

We hypothesize that the combination of MpMRI of the prostate with subsequent targeted biopsy (TB) may improve detection of prostate cancer and may therefore improve the follow-up of men after focal therapy (FT) to better identify patients that need a salvage treatment and when.

location_facility: Clinique La Croix du Sud Quint-Fonsegrives

location_facility: CHRU Brest - Hôpital de la Cavale Blanche


title: What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol

acronym: MIR-P

summary: Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.

ReferenceCitation: Economos G, Alexandre M, Perceau-Chambard E, Villeneuve L, Subtil F, Haesebaert J, Glehen O. What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol. BMC Palliat Care. 2022 May 23;21(1):84. doi: 10.1186/s12904-022-00976-7.

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

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand


title: A Randomised, Comparative, Prospective, Multicentre Study of the Efficacy of Nivolumab + Ipilimumab Versus Pazopanib Alone in Patients With Metastatic or Unresectable Advanced Sarcoma of Rare Subtype (RAR-Immune)

acronym: RAR-Immune

summary:
This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator.

In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 24 months, whereas in the control arm, patients will receive Pazopanib alone.

The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival.

lead_sponsor: Centre Leon Berard

location_facility: Institut Claudius Regaud - IUCT Oncopole


title: Outcome Measures and Biomarkers in a Cohort of Spinal Muscular Atrophy Type III/ IV Patients

acronym: SMOB

summary:
The "SMOB" project intends to contribute to fill the gap with reliable and operational outcome measures for type III and IV SMA. In analysing the reliability in imaging (spinal and muscular), electrophysiology analysis (MUNIX), and evaluate the evolution of respiratory function for 50 patients' cohort. The investigators would also take the opportunity to collect biologic samples in order to investigate genetic markers and to assess quality of life of patients by QoL-gNMD questionnaire. The investigators aim to build a database that will allow us to evaluate the effectiveness of a new therapy for adult SMA patients by studying the natural history of the disease. The investigators have distributed the various expertise in Work Package where several centers are involved.

This study is original in that it evaluates the parameters of qMRI and MUNIX in correlation with blood biomarkers. To our knowledge, there are no quantitative MRI (spinal and muscular) biomarkers and/or electrophysiological (MUNIX technique) highlighted for tracking the progression of the adult form of SMA type III and IV. This pilot study would allow identification of predictive markers of the disease progression, and to have validated, sensitive to change and relevant measurement tools that could be used as endpoints in future therapeutic trials.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service Laboratoire d'Explorations Fonctionnelles, Hôtel-Dieu, CHU Nantes

location_facility: Centre de Référence des Maladies Neuromusculaires - Pôle Neurosciences Cliniques, CHU Nice

location_facility: Service de Neurologie et d'explorations fonctionnelles, Hôpital Pierre-Paul Riquet, Place du Docteur Baylac

location_facility: Service de Neurologie - CHU Saint-Etienne

location_facility: Service des Maladies Neurologiques Rares

location_facility: Centre de référence des Maladies Neuromusculaires,Service de Neurologie, Hôpital de Hautepierre

location_facility: Service ENMG - Pathologies neuromusculaires, centre de référence en pathologie neuromusculaire Rhône-Alpes, Centre de référence SLA

location_facility: Service de Neurologie,Hôpital Raymond-Poincaré


title: Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Advanced Small Cell Ovarian Carcinoma of Hypercalcemic Type

acronym: PembroSCCOHT

summary: Advanced small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort

acronym: COCO-LATE

summary:
Several publications document the occurrence of symptoms that persist or occur late.

The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.

Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.

lead_sponsor: Tourcoing Hospital

location_country:
French Guiana
France

location_facility:
CH Sud Seine et Marne
CHRU Tours
CHRU Nancy
CHU Caen
CH Melun Marc Jacquet
AP-HP Hôpital Hôtel-Dieu
CH André Rosemon de Cayenne
CHU de Saint-Etienne
CH Tourcoing
Ch Auxerre
CHRU Lille
Centre Hospitalier Bretagne Atlantique


title: Molecular Profiles Associated With Resistance Development in Cancer Patients. Prospective Exploratory Study From 3 Cancer Locations: TNBC or Locally Advanced or Metastatic, Non-small Cell or Pancreatic or Bronchial Cancers

acronym: OncoSNIPE

summary: Precision medicine is considered to be one of the major issues in patient care. A lot of research has already proven itself with the implementation of targeted therapies including immunotherapies offering patients improved response and survival rates. But despite these major therapeutic advances, resistance to anti-cancer treatment is a major obstacle in the care of patients. Indeed, to date, many patients die of cancer, 9.6 million deaths worldwide in 2018. Nowadays, improving understanding of the mechanisms of resistance of cancer cells to anti-tumor treatments is therefore a major issue. The great diversity of molecular mechanisms involved in the phenomena of resistance to treatment, whether intrinsic (de novo, or primary) or acquired (secondary), constitutes a real therapeutic challenge. Indeed, a better understanding of the mechanisms of resistance would make it possible to explore new therapeutic strategies making it possible to circumvent these phenomena of escape in different types of cancer. It is in this context that the OncoSNIPE project was developed. The objective of this project is to identify early and / or late markers of resistance to treatment in 3 different pathologies concerned with resistance issues: triple negative breast cancer or Lum B or locally advanced or metastatic non -small-cell lung cancer or pancreatic cancer. In this project, in order to best cover the diversity of mechanisms involved in these resistances, the investigators propose a multidisciplinary approach with clinical, genomic, transcriptomic and immunological dimensions of the pathology through the data collected from 600 patients (200 for each pathology) for 4 years

ReferenceCitation: Vachenc S, Gobbo J, Moujarrebe SE, Desmoulins I, Gilabert M, Beau-Faller M, Mitry E, Girard N, Bertaut A, Dusetti N, Iovanna JL, Yousfi R, Pierrat F, Bruno R, Cueff A, Boidot R, Genne P. OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients. BMC Cancer. 2022 Jan 6;22(1):41. doi: 10.1186/s12885-021-09134-3.

lead_sponsor: Oncodesign SA

location_facility:
Chu de Poitiers
Institut Paoli Calmettes
Institut de Cancerologie de Lorraine
Institut Curie
CGFL
Centre Leon Berard
Institut Godinot
APHP - Hôpital Beaujon
Chu Dijon Bourgogne
Hopitaux Universitaires de Strasbourg
Chu de Besancon


title: Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain

acronym: E-PENEPA

summary: Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: University Hospital Lyon sud - Pierre Bénite

location_facility: CIC, Hospital University, Clermont Ferrand


title: Open Label Randomized Controlled Trial of Ultraprotective Ventilation Without Extracorporeal Circulation in Patients With COVID 19 Pneumonia and Moderate to Severe ARDS

summary:
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O).

Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.

ReferenceCitation: Richard JC, Yonis H, Bitker L, Roche S, Wallet F, Dupuis C, Serrier H, Argaud L, Thiery G, Delannoy B, Pommier C, Abraham P, Muller M, Aubrun F, Sigaud F, Rigault G, Joffredo E, Mezidi M, Terzi N, Rabilloud M. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial. Trials. 2021 Oct 11;22(1):692. doi: 10.1186/s13063-021-05665-z.

location_facility: Service de Réanimation Chirurgicale Hôpital de la Croix Rousse Hospices Civils de Lyon

location_facility: Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de Lyon

location_facility: Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de Lyon

location_facility: Service de Réanimation Centre hospitalier Annecy Genevois

location_facility: Service de Médecine Intensive Réanimation Hôpital de la Croix Rousse Hospices Civils de Lyon

location_facility: Service de Médecine Intensive Réanimation CHU Gabriel Montpied

location_facility: Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes

location_facility: Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon

location_facility: Service de Réanimation Clinique de la Sauvegarde

location_facility: Service de Médecine Intensive Réanimation Hôpital Nord - CHU Saint-Etienne

location_facility: Service de réanimation Polyvalente Centre Hospitalier Saint Joseph-Saint Luc


title: Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study

acronym: INASED

summary: The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.

ReferenceCitation: Bailly P, Egreteau PY, Ehrmann S, Thille AW, Guitton C, Grillet G, Reizine F, Huet O, Jaber S, Nowak E, L'her E. Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial. BMJ Open. 2021 Feb 19;11(2):e042284. doi: 10.1136/bmjopen-2020-042284.

location_facility:
CHU Tours
GHBS Lorient
CHU Poitiers
CHU Montpellier
CHU Rennes
CH Le Mans
CH Melun
CH Bourges
CHU de Brest
CH Morlaix
CH Corbeil Essonnes


title: Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome

acronym: DRESSEO

summary: Drug Hypersensitivity Syndrome or DRESS for "Drug Reaction with Eosinophilia and Systemic Symptoms" is a serious drug allergy which can be life-threatening for patients with serious organ damage. The pathophysiology of DRESS is still not fully understood. In particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteria. Likewise, there is no data about the origin of eosinophils and few data are available concerning immune polarization of T-cells or the involvement of innate lymphoid cells type 2 in the recruitment of eosinophils. Our preliminary data on increase activation markers membrane expression of cutaneous eosinophils suggest that this approach could allow the identification of endotypes in which eosinophils are involved and contribute to organ damages. The correlation between tissue infiltration of eosinophils and their degree of activation would then justify the development of targeted therapeutic strategies in DRESS syndrome (anti-IL-5 therapy?). The aim of the project is: 1) Evaluate the activation status of circulating and cutaneous eosinophils in patients with DRESS compared with drug induced maculopapular exanthema without or with eosinophilia (but do not fulfill DRESS criteria) and healthy subjects; 2) Understand the pathophysiological mechanisms at the origin of this eosinophilia.

lead_sponsor: University Hospital, Lille

location_facility: Assistance Publique - Hôpitaux de Paris - HENRI MONDOR

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille


title: Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage)

acronym: AmAREtTI

summary:
According to the Respreeza® Summary of Product Characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although subsequent infusions may be administered at home by the person responsible for care or by the patient.

Clinical data on self-administration of Respreeza® are however limited and the grounds for self-administration are left to the assessment of the attending physician, who needs to ensure that appropriate training is delivered.

In this context, CSL Behring would like to run a clinical study in order to assess the effectiveness of a home self-administration learning program in terms of switching to self-administration, and the long term maintenance of this administration.

lead_sponsor: CSL Behring

location_facility:
CHRU Tours
CHU Strasbourg
CHU Grenoble-Alpes
CHU Angers
CHU Lille
Hôpital Saint Joseph
CHU Nancy Brabois
Hôpital Bichat-Claude-Bernard
CHU Rennes - Hôpital Pontchaillou
Hospices Civils de Lyon
CHU Bordeaux - Hôpital Haut-Lévèque


title: LEft Main Oct Guided iNterventions

acronym: LEMON

summary: LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).

lead_sponsor: Institut Mutualiste Montsouris

location_facility:
Chu Clermont Ferrand
Chu Besancon
Clinique Saint Augustin
Chu Bordeaux
Institut hospitalier Jacques Cartier
Hôpital privé Saint Martin
Clinique Saint Hilaire
CHU Nîmes
Ch Chartres
Ch Annecy Genevois
Institut Mutualiste Montsouris


title: Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

acronym: SPLEEN

summary: Spleen could have been surgically removed for trauma, cancer, auto-immune disease, or to perform a diagnosis. Spleen could be non-functional due to radiotherapy or splenic artery embolism. These patients are at risks of infectious diseases due to encapsulated bacteria, cancer, and thromboembolism disease. The purpose of this study is to assess complications occurring in French patients without spleen and to implement new diagnostic tools for follow-up.

ReferenceCitation: Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica. 2014 Feb;99(2):392-8. doi: 10.3324/haematol.2013.092460. Epub 2013 Sep 20.

ReferenceCitation: Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. Review.

ReferenceCitation: Aiolfi A, Inaba K, Strumwasser A, Matsushima K, Grabo D, Benjamin E, Lam L, Demetriades D. Splenic artery embolization versus splenectomy: Analysis for early in-hospital infectious complications and outcomes. J Trauma Acute Care Surg. 2017 Sep;83(3):356-360. doi: 10.1097/TA.0000000000001550.

lead_sponsor: Poitiers University Hospital

location_facility:
C.H. de Tourcoing
C.H. de Valenciennes
C.H.U. de Montpellier
C.H. d'Angoulême
Hôtel-Dieu - CHU de Nantes
C.H. de Béthune
C.H.U. de Poitiers
C.H.U. de Lille
Hôpitaux de Chartres
C.H.U. de Rouen
C.H.U. de Toulouse


title: Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study

acronym: MEKANOS

summary:
Osteolytic bone metastases and myeloma bone lesions are responsible of long bone and vertebral fractures leading to restricted mobility, surgery and medullar compression that severely alter quality of life and that have a huge medico-economic impact. It has been estimated that 50% of the patients with bone metastasis will encounter bone complications. In the recent years, Bone Oncology Multidisciplinary Meetings have been developed to optimize bone metastases management for each patient in harmony with oncology program.

The assessment of the fracture risk of bone metastasis remains fairly empirical and is based on simple radiography. The Mirel's score for long bones is focused on the extent of cortical defect caused by bone metastasis to identify high-risk patients at risk of fracture during surgery. It is old, little used in routine and lacks sensitivity and specificity. The SINS (Spinal Instability Neoplastic Score) score is the reference for vertebrae. Today, most patients with fracture-risk bone metastasis benefit from a lesion-centered CT scan to better characterize its extent and position but the interpretation remains qualitative. Metastases are considered as an air cavity and the mechanical properties of the tumor are not evaluated. However, many other parameters from the CTscan are available such as cortical or trabecular compartment densitometry, cortical thickness, tumor volume, and position of lysis in the bone.

Based on experience acquired by the service in the evaluation of bone mechanical strength on benign bones, the investigator aim at integrating in the numerical simulation the mechanical properties of both bone and tumor, in order to evaluate the mechanical strength of the pathological bone using a numerical simulation model (finite element analysis-FEA).

MEKANOS will enroll patients with bone metastases of breast, lung, kidney, thyroid or bladder cancer and myeloma lesions affecting the vertebrae or the upper end of the femur.

The resistance obtained will be compared to that of an intact bone. The best predictive parameters of mechanical strength (position of lysis, tumor nature, and bone architecture) will be then determined. Finally, the added value of this technique in relation to historical fragility scores (Mirel's and SINS scores) will be assessed.

The ultimate goal is to provide tools to assess fracture risk and improve the preventive management of bone metastases in harmony with the referring oncologist

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud

location_facility: Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm

location_facility: Service de rhumatologie, CHU de Poitiers

location_facility: Service de rhumatologie, CHU de Saint Etienne

location_facility: Service d'onco-rhumatologie, Centre Oscar Lombret

location_facility: Service de radiothérapie, Institut Jean-Perrin

location_facility: Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris

location_facility: Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian

location_facility: Service de rhumatologie, CHU de Grenoble