title: An Open-Label, Multicenter, Dose-Escalation Phase Ib Study With Expansion Phase to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Emactuzumab and RO7009789 Administered in Combination in Patients With Advanced Solid Tumors

summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in combination in participants with locally advanced or metastatic solid tumors that are not amenable to standard treatment. This study will be conducted in two parts: a dose-finding stage (Part I) and an expansion stage (Part II).

ReferenceCitation: Machiels JP, Gomez-Roca C, Michot JM, Zamarin D, Mitchell T, Catala G, Eberst L, Jacob W, Jegg AM, Cannarile MA, Watson C, Babitzki G, Korski K, Klaman I, Teixeira P, Hoves S, Ries C, Meneses-Lorente G, Michielin F, Christen R, Rüttinger D, Weisser M, Delord JP, Cassier P. Phase Ib study of anti-CSF-1R antibody emactuzumab in combination with CD40 agonist selicrelumab in advanced solid tumor patients. J Immunother Cancer. 2020 Oct;8(2). pii: e001153. doi: 10.1136/jitc-2020-001153.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
France
Belgium

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale


type: EudraCT Number

title: PHASE IA/IB, OPEN-LABEL, MULTICENTER, MULTIPLE ASCENDING DOSE STUDY FOLLOWED BY AN EXTENSION PHASE TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND ACTIVITY OF RO6927005, AN ANTI-MESOTHELIN (MSLN) RECOMBINANT CYTOLYTIC FUSION PROTEIN (cFP), ADMINISTERED EITHER ALONE (PART A) OR IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL (PART B) IN PATIENTS WITH MESOTHELIN-POSITIVE METASTATIC AND/OR LOCALLY ADVANCED MALIGNANT SOLID TUMORS

summary:
This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study will establish the safety and tolerability profile of RO6927005 and will be conducted in two parts.

In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single patient cohorts will be used to investigate increasing doses until a first dose-limiting toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related reactions), whichever comes first. At least 3 patients will be enrolled in each cohort thereafter, which, if required, can be expanded with additional patients. Part B of the study will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3 patients) followed by an extension phase of RO6927005 given in combination with gemcitabine/nab-paclitaxel.

Preliminary clinical activity will be explored throughout the study. Patients will be treated until disease progression and/or lack of clinical benefit, unacceptable toxicities, withdrawal from treatment for other reasons, death, pregnancy or termination of the study by the Sponsor, whichever comes first.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

location_country:
Denmark
United States
Canada
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy 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 during surgery.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Cancer Center at the University of Virginia

intervention_type: Radiation


title: LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES

summary: The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country: Japan France Spain Taiwan

location_facility:
CHU de Rennes - Hôpital Pontchaillou
Hospital Vall D´Hebron
Aichi Cancer Center Hospital
National Taiwan University Hospital
Hospital Universitari Vall d'Hebron
Gustave Roussy

status_simplified: Ongoing


title: An Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptomatic Management of Myotonia in Adult Patients With Non-dystrophic Myotonic Disorders

summary: This is a non-interventional, prospective, observational, multicentre study to evaluate the long-term safety and effectiveness of Namuscla in adult patients with NDM.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Lupin Ltd.

location_country:
Germany
France
United Kingdom

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Universitätsklinikum Ulm, Klinik für Neurologie

location_facility: Hôpital Universitaire de La Pitié Salpêtrière

location_facility: St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum


title: A Pivotal, International, Randomised, Double-blind, Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome

summary: This trial aims to investigate the efficacy, safety and tolerability of sodium valproate in the treatment of patients with Wolfram syndrome. 70 paediatric and adult patients will be randomised 2:1 to receive either sodium valproate or placebo at 6 international centres.

status: Unknown status

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: University of Birmingham

location_country:
Poland
France
Spain
United Kingdom

location_facility: CHU de Montpellier, Hopital Gui de Chauliac

location_facility: Unidad de Gestión Clínica Almería Periferia. Distrito Sanitario Almería

lead_sponsor_type: academique


type: Other Identifier

title: Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients

summary: Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

ReferenceType: background

ReferenceCitation: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Wárlám-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. Epub 2007 Jun 18.

ReferenceCitation: Cajucom CC, Tsangaris TN, Nemoto T, Driscoll D, Penetrante RB, Holyoke ED. Results of salvage mastectomy for local recurrence after breast-conserving surgery without radiation therapy. Cancer. 1993 Mar 1;71(5):1774-9.

ReferenceCitation: Elkhuizen PH, van de Vijver MJ, Hermans J, Zonderland HM, van de Velde CJ, Leer JW. Local recurrence after breast-conserving therapy for invasive breast cancer: high incidence in young patients and association with poor survival. Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):859-67.

ReferenceCitation: Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.

ReferenceCitation: Osborne MP, Borgen PI, Wong GY, Rosen PP, McCormick B. Salvage mastectomy for local and regional recurrence after breast-conserving operation and radiation therapy. Surg Gynecol Obstet. 1992 Mar;174(3):189-94.

ReferenceCitation: Sanders ME, Scroggins T, Ampil FL, Li BD. Accelerated partial breast irradiation in early-stage breast cancer. J Clin Oncol. 2007 Mar 10;25(8):996-1002. Review. Erratum in: J Clin Oncol. 2007 Aug 10;25(23):3561.

ReferenceCitation: Veronesi U, Volterrani F, Luini A, Saccozzi R, Del Vecchio M, Zucali R, Galimberti V, Rasponi A, Di Re E, Squicciarini P, et al. Quadrantectomy versus lumpectomy for small size breast cancer. Eur J Cancer. 1990;26(6):671-3.

ipd_sharing_description: data from this clinical trial will be shared with the previous PAPBI clinical trial

lead_sponsor: The Netherlands Cancer Institute

location_country: Netherlands France Portugal Spain

location_facility: University Medical Center Utrecht (UMCU)

location_facility: University General Hospital Valencia-Erasa


title: Medium Cost Effectiveness of Automated Non-Invasive Ventilation Outpatient Set Up vs Standard Fixed Level Non-Invasive Ventilation Inpatient Set Up In Obese Patients With Chronic Respiratory Failure

acronym: OPIP

summary:
Obesity is an escalating issue, with an accompanying increase in referrals of patients with obesity-related respiratory failure. Currently, these patients are electively admitted to hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether outpatient initiation is as effective as inpatient set-up. The investigators hypothesise that outpatient set up using an auto-titrating NIV device will be more cost effective than nurse-led inpatient titration and set-up.

The investigators will undertake a multi-national, multi-centre randomised controlled trial.

Subjects will be randomised to receiving usual inpatient set-up, which will include nurse-led initiation of NIV or outpatient set-up with an automated NIV device. Subjects will be stratified according to trial site, gender and previous use of NIV or continuous positive airway pressure. Assuming 10% drop out rate, a total sample of 82 patients will be required. Cost effectiveness will be evaluated using standard treatment costs and health service utilisation and using health related quality of life measures (SRI and EQ5D). Change in the severe respiratory insufficiency (SRI) questionnaire will be based on analysis of covariance (ANCOVA) adjusting for the baseline measurements between the two arms of patients.

status: Completed

ReferenceType: derived

ReferenceCitation: Murphy PB, Patout M, Arbane G, Mandal S, Kaltsakas G, Polkey MI, Elliott M, Muir JF, Douiri A, Parkin D, Janssens JP, Pépin JL, Cuvelier A, Flach C, Hart N. Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial. Thorax. 2022 Sep 2. pii: thoraxjnl-2021-218497. doi: 10.1136/thorax-2021-218497. [Epub ahead of print]

ipd_sharing: No

ipd_sharing_description: No plan to share individual participant data

lead_sponsor: Guy's and St Thomas' NHS Foundation Trust

location_country:
France
United Kingdom

location_facility: Leeds Teaching Hospital NHS Foundation Trust

location_facility: Royal Brompton and Harefield NHS Foundation Trust

intervention_type: Device

status_simplified: Completed


title: Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head

summary: The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.

ReferenceType: result

ReferenceCitation: Gómez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendaño-Solá C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Safely Healed with Autologous, Expanded, Bone Marrow-Derived Mesenchymal Stromal Cells in a Multicentric Trial with Minimum 5 Years Follow-Up. J Clin Med. 2021 Feb 1;10(3). pii: 508. doi: 10.3390/jcm10030508.

lead_sponsor: Universidad Autonoma de Madrid

location_country: Germany France Spain Italy

location_facility: Department of Orthopaedic Surgery, Hôpital Henri Mondor

location_facility: Department of Orthopaedic Surgery, CHU Tours

location_facility: Department of Orthopaedic Trauma, University of Ulm

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

intervention_type: Biological


title: A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients

summary: This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

location_country: Netherlands Poland France


title: A Post Market Clinical Evaluation of Deep Brain Stimulation as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication

summary:
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.

lead_sponsor: Abbott Medical Devices

location_country: Germany France Turkey

location_facility:
University Hospital Bonn
CHU Laennec
University Hospital of Duesseldorf
University Hospital Regensburg
Erciyes University Medicine School
Hopital Neurologique


title: A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

lead_sponsor: Novartis Pharmaceuticals

source: euctr

location_country: Germany France

summary: The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).


title: An International Phase III Randomised Trial Comparing the Propofol Consumption During General Anaesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia Alone in ASA III Patients With Increased Risk of Perioperative Cardiac Complications.

summary: The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintenance period of general anaesthesia.

lead_sponsor: Air Liquide SA

location_facility: Groupe Hospitalier Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand


title: A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy

summary: An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard intensive therapy.

lead_sponsor: Onxeo

location_facility:
CHU Lapeyronie
Christie Hospital NHS Trust
Hôpital St. Louis
Uni Hospital Marburg
Universitätsklinikum Ulm
Uniklinik Homburg


title: A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes

summary: The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.

lead_sponsor: Boehringer Ingelheim

location_country: Germany France Spain

location_facility: Boehringer Ingelheim Investigational Site


title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

summary: The drug that will be investigated in the study is an antibody, GEN1047. Since this is the first study of GEN1047 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1047 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1047. GEN1047 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1047. The study consists of two parts: Part 1 tests increasing doses of GEN1047 ("escalation"), followed by Part 2 ("expansion") which tests the recommended GEN1047 dose from Part 1.

lead_sponsor: Genmab

location_country: Denmark France Spain

location_facility: Rigshospitalet (Copenhagen University Hospital)


title: PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

summary:
Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.

Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.

primary_purpose: Prevention

ReferenceCitation: Weyers S, Capmas P, Huberlant S, Dijkstra JR, Hooker AB, Hamerlynck T, Debras E, De Tayrac R, Thurkow AL, Fernandez H. Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):151-157. doi: 10.1016/j.jmig.2021.07.017. Epub 2021 Jul 31.

ipd_sharing_description: No sharing of individual participant data is planed

lead_sponsor: Womed

location_country: Netherlands France Belgium

location_facility:
Bergman Clinics
UZ Gent
CHU Bicêtre (APHP)
CHU Nîmes
Isala Zwolle
Zaans Medical Center


title: Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting

acronym: Maxibone

summary: A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.

study_start_date_type: Anticipated

ReferenceCitation: Gjerde C, Mustafa K, Hellem S, Rojewski M, Gjengedal H, Yassin MA, Feng X, Skaale S, Berge T, Rosen A, Shi XQ, Ahmed AB, Gjertsen BT, Schrezenmeier H, Layrolle P. Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial. Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9.

ReferenceCitation: Rojewski MT, Lotfi R, Gjerde C, Mustafa K, Veronesi E, Ahmed AB, Wiesneth M, Körper S, Sensebé L, Layrolle P, Hellem S, Schrezenmeier H. Translation of a standardized manufacturing protocol for mesenchymal stromal cells: A systematic comparison of validation and manufacturing data. Cytotherapy. 2019 Apr;21(4):468-482. doi: 10.1016/j.jcyt.2019.03.001. Epub 2019 Mar 27.

ipd_sharing_description: De-identified individual participants data for all primary and secondary outcome measures will be made available

lead_sponsor: University of Bergen

location_country: Norway Denmark France Spain

location_facility: University of Bergen, Institute of Clonical Dentistry

location_facility: Syddansk Universitet SDU (University Hospital of Southern Denmark)

intervention_type: Combination Product


title: A Randomized Phase I Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.

summary: This is a multicenter, open-label, two arms, randomized, phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).

lead_sponsor: Transgene

location_country:
United States
United Kingdom
France

location_facility: Aintree University Hospital NHS Fondation Trust


title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer

summary: The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.

status: Withdrawn

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
United States
Spain
France

location_facility:
Dana Farber Cancer Institute
Hospital Clinic I Provincial
Hospital Madrid Norte Sanchinarro
CHU de Besancon Hopital Jean Minjoz
Institut Catala d'Oncologia
Gustave Roussy


title: Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study

acronym: INDUCATH

summary:
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.

Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.

Secondary objectives:

To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA

ipd_sharing: Undecided

lead_sponsor: AZ Sint-Jan AV

location_country:
Germany
France
United Kingdom
Belgium

location_facility: Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

intervention_type: Procedure


title: SYNTAX III REVOLUTION Trial: A Randomized Study to Evaluate the Feasibility of Heart-Team Clinical Decision Making Regarding the Optimal (Surgical or Percutaneous Based) Revascularization Strategy in Patients With Complex Coronary Artery Disease, Based on Non-invasive Coronary CT Angiography (CTA) Imaging Utilising High-definition GE RevolutionTM Multi-slice CT and HeartFlow FFRCT Compared to the Current Standard of Care With Conventional Invasive Coronary Angiography (CA)

acronym: SYNTAX III

summary:
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in patients with complex coronary artery disease. Each patient will undergo an angiogram and CT scan per standard of care. The randomization strategy in this study is not between patients but between two teams of doctors, the so-called "Heart Teams", will be randomized: in the first round, team 1 assesses the angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment would be the best to treat complex coronary artery disease. In the second round, both teams see the imaging method that they did not see in the first round, and make the decision again. The final decision on the clinical treatment strategy is at the sole discretion of the Heart Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing this final decision.

Hypothesis: Determination of the best treatment strategy for coronary artery disease based on a CT scan will result in similar decisions as based on invasive coronary angiography.

time_perspective: Cross-Sectional

ReferenceCitation: Andreini D, Modolo R, Katagiri Y, Mushtaq S, Sonck J, Collet C, De Martini S, Roberto M, Tanaka K, Miyazaki Y, Czapla J, Schoors D, Plass A, Maisano F, Kaufmann P, Orry X, Metzdorf PA, Folliguet T, Färber G, Diamantis I, Schönweiß M, Bonalumi G, Guglielmo M, Ferrari C, Olivares P, Cavallotti L, Leal I, Lindeboom W, Onuma Y, Serruys PW, Bartorelli AL; SYNTAX III REVOLUTION Investigators. Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e007607. doi: 10.1161/CIRCINTERVENTIONS.118.007607. Epub 2019 Dec 13.

ReferenceCitation: Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgräber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Lüscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.

ipd_sharing_description:
The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy.

Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.

lead_sponsor: ECRI bv

location_country: Italy Switzerland France Belgium Germany


title: Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)

acronym: RELAX-OAB

summary: The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.

lead_sponsor: Axonics Modulation Technologies, Inc.

location_country:
Netherlands
France
United Kingdom
Belgium

location_facility:
University College London Hospital
Chu De Nantes - Hôtel-Dieu
UZ Leuven
Maastricht University Medical Center
Erasmus Medical Center
Hospices Civils de Lyon


title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis.

summary: The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis

ReferenceCitation: Borgwardt L, Stensland HM, Olsen KJ, Wibrand F, Klenow HB, Beck M, Amraoui Y, Arash L, Fogh J, Nilssen Ø, Dali CI, Lund AM. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015 Jun 6;10:70. doi: 10.1186/s13023-015-0286-x.

ReferenceCitation: Borgwardt L, Thuesen AM, Olsen KJ, Fogh J, Dali CI, Lund AM. Cognitive profile and activities of daily living: 35 patients with alpha-mannosidosis. J Inherit Metab Dis. 2015 Nov;38(6):1119-27. doi: 10.1007/s10545-015-9862-4. Epub 2015 May 28.

ReferenceCitation: Harmatz P, Cattaneo F, Ardigò D, Geraci S, Hennermann JB, Guffon N, Lund A, Hendriksz CJ, Borgwardt L. Enzyme replacement therapy with velmanase alfa (human recombinant alpha-mannosidase): Novel global treatment response model and outcomes in patients with alpha-mannosidosis. Mol Genet Metab. 2018 Jun;124(2):152-160. doi: 10.1016/j.ymgme.2018.04.003. Epub 2018 Apr 18.

ReferenceCitation: Borgwardt L, Guffon N, Amraoui Y, Dali CI, De Meirleir L, Gil-Campos M, Heron B, Geraci S, Ardigò D, Cattaneo F, Fogh J, Van den Hout JMH, Beck M, Jones SA, Tylki-Szymanska A, Haugsted U, Lund AM. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018 Nov;41(6):1215-1223. doi: 10.1007/s10545-018-0185-0. Epub 2018 May 30.

lead_sponsor: Zymenex A/S

location_country:
Denmark
Poland
United Kingdom
France
Germany

location_facility: Hôpital Trousseau, Service de neuropédiatrie, Centre Référence des Maladies Lysosomales, 26 avenue du Docteur Arnold Netter

location_facility: Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin, Langenbeckstrasse 1

location_facility: The Children's Memorial Health Institute Warsaw, Department of Metabolic Diseases, Al Dzieci Polskich 20

location_facility: Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9

location_facility: Genetic Medicine, 6th floor, St Mary's Hospital, Oxford Road,

location_facility: Hôpital Femme Mère Enfant, Lyon, 59 boulevard Pinel


title: A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

summary: This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

ReferenceCitation: Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019)

lead_sponsor: Novo Nordisk A/S

location_country:
Spain
United Kingdom
Austria
France
Germany


title: A Multi-centre, Two-stage, Open Label Phase II Study to Assess the Efficacy and Safety of APO866 in the Treatment of Patients With Advanced Melanoma.

summary: This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth inhibition in cultures of human melanoma cells as well as in animal models with subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated in a phase I study that treated 24 patients with advanced cancer. In that study one of the two patients with advanced melanoma had a stable disease for 5 months with size reduction of some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.

location_country: Austria Germany France Switzerland

location_facility: Department of Dermatology, University Hospital of Zürich

location_facility: Department of Dermatology, Hopital Henri Modor

location_facility: Department of Dermatology, Charité University Hospital Berlin

location_facility: University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University

location_facility: Department of Dermatology, Medical University Graz


title: Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART

acronym: APPART

summary: This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.

status: Not yet recruiting

lead_sponsor: University Hospital, Toulouse

location_facility: HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant


title: A Phase II Study of Durvalumab (MEDI 4736) Maintenance in Frail Limited Disease Small Cell Lung Cancer Patients After Thoracic Chemoradiotherapy (CRT)

acronym: DURVALUNG

summary:
This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients.

Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities.

During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin.

Patients showing a disease control (defined as stable disease [SD], partial response [PR], or complete response [CR] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care.

Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

ipd_sharing_description:
Unicancer will share de-identified individual data that underlie the results reported.

A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Polyclinique de Limoges -Site Clinique Chénieux

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Hopital Nord Ouest - Villefranche sur Saône


title: French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings

acronym: FOLLOW

summary:
Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation.

We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: PERPIGNAN - CH St Jean - Hématologie Clinique

location_facility: ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: APHP - Hôpital Pitié Salpêtrière - Hématologie

location_facility: RENNES - Hôpital Pontchaillou - Hématologie

location_facility: LILLE GHICL - Hôpital Saint Vincent de Paul

location_facility: BEZIERS - Centre Hospitalier - Hématologie

location_facility: ARGENTEUIL - Centre hospitalier Victor Dupouy

location_facility: NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

location_facility: RENNES - CHU Pontchaillou - Hématologie Clinique

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

location_facility: ROUEN - Centre Henri Becquerel - Service Hématologie Clinique

location_facility: BREST - Hôpital Morvan - Hématologie Clinique


title: PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer.

acronym: PAROLA

summary:
This is an international multicenter, randomized and comparative phase III study designed to demonstrate whether para-aortic lymphadenectomy followed by tailored chemoradiation for PALN (para-aortic lymph node) metastasis group is associated with increased disease-free survival compared to patients staged with PET/CT only followed by chemoradiation in patients with locally advanced cervical cancer (LACC).

In this trial, patients will be assigned in one of the two following treatments arms:

Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II guidelines.

Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy.

Each patient will be followed up for 5 years.

lead_sponsor: Institut Claudius Regaud

location_country: France Spain Italy

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

intervention_type: Other


title: Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs

acronym: GPCUS

summary: The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

primary_purpose: Diagnostic

ReferenceCitation: Mumoli N, Vitale J, Giorgi-Pierfranceschi M, Sabatini S, Tulino R, Cei M, Bucherini E, Bova C, Mastroiacovo D, Camaiti A, Palmiero G, Puccetti L, Dentali F; PRACTICUS Study Investigators. General Practitioner-Performed Compression Ultrasonography for Diagnosis of Deep Vein Thrombosis of the Leg: A Multicenter, Prospective Cohort Study. Ann Fam Med. 2017 Nov;15(6):535-539. doi: 10.1370/afm.2109.

ReferenceCitation: Mumoli N, Vitale J, Cocciolo M, Cei M, Brondi B, Basile V, Sabatini S, Gambaccini L, Carrara I, Camaiti A, Giuntoli S, Dentali F. Accuracy of nurse-performed compression ultrasonography in the diagnosis of proximal symptomatic deep vein thrombosis: a prospective cohort study. J Thromb Haemost. 2014 Apr;12(4):430-5. doi: 10.1111/jth.12522.

ReferenceCitation: Pomero F, Dentali F, Borretta V, Bonzini M, Melchio R, Douketis JD, Fenoglio LM. Accuracy of emergency physician-performed ultrasonography in the diagnosis of deep-vein thrombosis: a systematic review and meta-analysis. Thromb Haemost. 2013 Jan;109(1):137-45. doi: 10.1160/TH12-07-0473. Epub 2012 Nov 8. Review.

ReferenceCitation: Lee JH, Lee SH, Yun SJ. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department: A meta-analysis. Medicine (Baltimore). 2019 May;98(22):e15791. doi: 10.1097/MD.0000000000015791.

lead_sponsor: University Hospital, Caen

location_facility:
Lons-le-Saunier
Troarn
Le Chesnay
Ouistreham
Le pont de montvert
Sannerville
Avranches
Saix
Potigny
Condé sur vire
Bain de Bretagne
Honfleur
Colombelles
Ifs
Ploerdut
Percy
Le Molay Littry
Bayeux
Paris rue de Rome

intervention_type: Diagnostic Test


title: Randomised Phase II Study Evaluating Trifluridine/Tipiracil Plus Oxaliplatin Versus FOLFOX in Patients With Gastric, Oesophagus or Gastroesophageal Junction Adenocarcinoma Locally Advanced, Recurrent or Metastatic, Ineligible for Triplet Chemotherapy

acronym: LOGICAN

summary: Oxaliplatin in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

location_facility: Institut de cancérologie Strasbourg Europe


title: Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study

acronym: PRO-SURFASA

summary:
Autoimmune hepatitis (AIH) is a chronic liver disease, which is characterized by the increase of immunoglobulin G (IgG) level, the presence of auto-antibodies and a typical histology, in the absence of other liver disease.

Due to the heterogeneity of AIH manifestations, different scoring systems have been validated in order to make a reliable diagnosis. The two most recent scoring systems are: the revised International Autoimmune Hepatitis Group (IAIHG) criteria and the IAIHG simplified criteria. The second one is recommended by the European Association for the Study of the Liver (EASL) clinical practice guidelines (CPGs).

The EASL clinical practice guidelines suggests that the treatment of ASAIH (Acute Severe AIH) is high doses of corticosteroids (superior to 1mg/kg/day) as early as possible and a lack of improvement within seven days should lead to listing for emergency liver transplantation (LT). However, the "lack of improvement" is not objectively defined and the grading of recommendation is III (Opinions of respected authorities).

The hypothesis of the study is that the previously developed decisional score on a retrospective series will prospectively allow the differentiation between patients with ASAIH (Acute Severe AIH) who respond to corticosteroid therapy and should be maintained on treatment and patients who do not respond and should be rapidly evaluated for LT. The score will be computed at day 3 since corticosteroid introduction.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie

location_facility: CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie

location_facility: AP-HP, Hopital Cochin Service Hepatologie

location_facility: CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie

location_facility: AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie

location_facility: CHU Grenoble Alpes Hopital Nord, Service Hepato-gastro-enterologie

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

location_facility: CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive

location_facility: CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive

location_facility: CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition

location_facility: CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie

location_facility: CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie

location_facility: CHU Nice, Hopital de l'Archet 2, Service Hepatologie

location_facility: CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie

location_facility: CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition

location_facility: APHP, Hopital Jean Verdier, Service Hepatologie

location_facility: CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs

location_facility: CHU Toulouse, Hopital Rangueil, Service Hepatologie

location_facility: CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie

location_facility: CHU La Miletrie, Service Hepato-gastro-enterologie

location_facility: CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition

location_facility: CHU Angers, Service Hepato-gastro-enterologie

location_facility: CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie

location_facility: Hopital Saint Joseph, Service Hepato-gastro-enterologie

location_facility: CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie

location_facility: CHU Rouen, Service d'hepatogastro-enterologie

location_facility: APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie


title: Transplantation After Complete Response In Patients With T-cell Lymphoma

acronym: TRANSCRIPT

summary:
Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL.

The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Ch de Valenciennes - Hopital Jean Bernard

location_facility: Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

location_facility: Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,

location_facility: Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

location_facility: Service Hématologie, Institut Curie - Hôpital René HUGUENIN

location_facility: Institut Cancerologie & Hematologie St-Etienne


title: Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future

acronym: TARGETMONITO

summary: Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.

location_facility: Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul

location_facility: CHRU de Nancy - Hôpital de Brabois Adulte

location_facility: Institut du Cancer Avignon - Institut Sainte Catherine


title: A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)

lead_sponsor: Sanofi Pasteur, a Sanofi Company

type: Registry Identifier

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Germany
France
United Kingdom

location_facility:
Investigational Site Number: 2500024
Investigational Site Number: 2760091
Investigational Site Number: 2760083
Investigational Site Number: 2760025
Investigational Site Number: 2500063
Investigational Site 2500059
Investigational Site Number: 8260047
Investigational Site Number: 2760043
Investigational Site Number: 2500014
Investigational Site Number: 8260020
Investigational Site Number: 8260035
Investigational Site Number: 8260050
Investigational Site Number: 2760035
Investigational Site Number: 8260016
Investigational Site Number: 2760007
Investigational Site Number: 2500022
Investigational Site Number: 2500045
Investigational Site Number: 2760001
Investigational Site Number: 2500029
Investigational Site Number: 2500060
Investigational Site 8260023
Investigational Site Number: 2500026
Investigational Site Number: 2500027
Investigational Site Number: 2500006
Investigational Site Number: 8260013
Investigational Site Number: 2500004
Investigational Site Number: 8260056
Investigational Site Number: 2500010
Investigational Site Number: 8260038
Investigational Site Number: 2760038
Investigational Site Number: 8260094
Investigational Site 2500030
Investigational Site Number: 2500012
Investigational Site Number: 2500019
Investigational Site Number: 8260067
Investigational Site Number: 8260004
Investigational Site Number: 8260006
Investigational Site Number: 2760034
Investigational Site 2500046
Investigational Site Number: 2500064
Investigational Site Number: 8260088
Investigational Site Number: 8260077
Investigational Site 8260005
Investigational Site 8260051
Investigational Site Number: 8260079
Investigational Site 8260043
Investigational Site Number: 8260083
Investigational Site Number: 2500035
Investigational Site Number: 8260097
Investigational Site Number: 8260036
Investigational Site 8260009
Investigational Site 2760006
Investigational Site Number: 8260093
Investigational Site Number: 8260104
Investigational Site Number: 2760020
Investigational Site Number: 2760014
Investigational Site Number: 2760044
Investigational Site Number: 8260029
Investigational Site 2500007
Investigational Site 8260082
Investigational Site Number: 8260045
Investigational Site Number: 2500057
Investigational Site Number: 2500034
Investigational Site Number: 8260027
Investigational Site Number: 2760076
Investigational Site Number: 2500032
Investigational Site Number: 2500054
Investigational Site Number: 2500042
Investigational Site Number: 2760028
Investigational Site 2500020
Investigational Site Number: 2500049
Investigational Site Number: 2760051
Investigational Site Number: 2760008
Investigational Site 2500021
Investigational Site Number: 8260008
Investigational Site Number: 2500065
Investigational Site 8260018
Investigational Site 8260026
Investigational Site Number: 2760023
Investigational Site 2500008
Investigational Site Number: 2760003
Investigational Site 2500041
Investigational Site Number: 8260072
Investigational Site 8260028
Investigational Site Number: 2760027
Investigational Site Number: 8260025
Investigational Site 2760010
Investigational Site Number: 8260021
Investigational Site Number: 8260054
Investigational Site Number: 8260076
Investigational Site Number: 2760030
Investigational Site Number: 2760018
Investigational Site Number: 2760016
Investigational Site Number: 8260053
Investigational Site Number: 8260063
Investigational Site 8260064
Investigational Site 2760029
Investigational Site Number: 2760019
Investigational Site Number: 8260037
Investigational Site Number: 2760005
Investigational Site Number: 2500043
Investigational Site Number: 8260031
Investigational Site Number: 8260017
Investigational Site Number: 2500040
Investigational Site Number: 2760013
Investigational Site Number: 8260074
Investigational Site Number: 8260084
Investigational Site Number: 2500011
Investigational Site Number: 2500050
Investigational Site Number: 2500055
Investigational Site Number: 2760047
Investigational Site Number: 8260060
Investigational Site 2500005
Investigational Site Number: 8260022
Investigational Site 2500002
Investigational Site Number: 2500039
Investigational Site 2500028
Investigational Site Number: 8260010
Investigational Site Number: 2500052
Investigational Site Number: 2760032
Investigational Site Number: 8260034
Investigational Site Number: 8260014
Investigational Site Number: 2500058
Investigational Site Number: 2760094
Investigational Site Number: 8260105
Investigational Site 8260046
Investigational Site Number: 2500037
Investigational Site Number: 8260062
Investigational Site Number: 8260019
Investigational Site Number: 2500047
Investigational Site Number: 2760054
Investigational Site Number: 2500038
Investigational Site Number: 8260003
Investigational Site Number: 2500009
Investigational Site Number: 2500003
Investigational Site Number: 8260011
Investigational Site Number: 8260085
Investigational Site Number: 8260092
Investigational Site Number: 8260032
Investigational Site Number: 2760061
Investigational Site Number: 8260044
Investigational Site Number: 2500023
Investigational Site Number: 8260065
Investigational Site Number: 8260058
Investigational Site Number: 2500001
Investigational Site Number: 8260001
Investigational Site Number: 2760067
Investigational Site Number: 8260068
Investigational Site Number: 8260052
Investigational Site Number: 2500015

summary:
The purpose of this study is to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who are not eligible to receive palivizumab.

The visit frequency will be 1 in-person dosing/randomization visit, with monthly safety follow-up electronic contacts through the first 6 months post dosing/randomization. The study will also include a 12-month (Day 366) final follow-up telephone call.

The study duration will be 12 months post-dosing/randomization.


title: Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

acronym: NITAZO-SPORE

summary: Microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. The main immunocompromised population affected by these infections consists of solid organ transplant recipients (SOT), mainly kidney (~70% of cases in immunocompromised patients). In this population, the infection is severe, and becomes chronic in the absence of appropriate care, the species Enterocytozoon bieneusi being found in more than 95% of these cases. Reducing immunosuppression (adjustment of immunosuppressive therapy) can sometimes be enough to eliminate the pathogen. However, in some cases, specific treatment is necessary. The only molecule whose efficacy has been proven to date to treat infections caused by E. bieneusi is fumagillin (FLISINT®), however its production has been stopped for almost 2 years. Due to the therapeutic impasse, the use of nitazoxanide (ALINIA®) to treat E. bieneusi microsporidiosis is becoming common, despite the lack of proof of its efficacy. It seems important and urgent to evaluate the relevance of the use of nitazoxanide, particularly in SOT, for the treatment of intestinal microsporidiosis due to E. bieneusi.

time_perspective: Retrospective

lead_sponsor: University Hospital, Clermont-Ferrand

location_country: France Guadeloupe

location_facility: AP-HP Hopitaux Universitaires Henri-Mondor


title: Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

acronym: ICARE

summary: The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

location_facility: Hôpital Européen de Paris GVM la Roseraie


title: Prospective and Multicentric Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.

acronym: REPARP

summary:
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1/2 mutations.

This translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer:

The main study concerns 80 patients eligible for PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration.
The sub-study concerns 40 patients in progression disease under PARPi alone.

For each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study.

location_facility: Institut Regional Du Cancer de Montpellier

location_facility: Centre de Cancerologie Du Grand Montpellier

location_facility: CENTRE ARMORICAIN DE RADIOTHERAPIE, IMAGERIE MEDICALE ET ONCOLOGIE - Hôpital privé des Côtes d'Armor

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST St-Herblain


title: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study

acronym: ENDOVIE

summary: This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre ONCOGARD - Institut de cancérologie du Gard

location_facility: Sainte-Catherine Institut du Cancer Avignon-Provence

location_facility: Centre d'Oncologie et de Radiothérapie 37

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon


title: A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults

acronym: CaboCombo

summary: The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Ipsen

location_country: France Greece

location_facility: Groupe Hospitalier Saint-André (Bordeaux)

location_facility: Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau

location_facility: Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu

location_facility: Centre Hospitalier Universitaire (CHU) Henri Mondor

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Centre Hospitalier Universitaire (CHU) de Angers

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Centre Hospitalier de Boulogne-sur-mer, Service Oncologie

location_facility: Centre d'Urologie Site Médipole - Centre Catalan d'Urologie

location_facility: Centre Hospitalier Régional D'orléans Hôpital de La Source

location_facility: Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Institut Ste Catherine - Institut du Cancer Avignon Provence Oncologie médicale

location_facility: Centre Finisterien de Radiotherapie et d'Oncologie

location_facility: Centre de Lutte Contre le Cancer Jean PERRIN

location_facility: Groupe Hospitalier De La Rochelle - Ré - Aunis

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied


title: Assessment of the Impact of the Postponement of Surgery on the Postoperative Morbidity After Sars-cov-2 Infection in 2022

summary: The deployment of vaccination against SARS-CoV-2 from 2021 led to a modification in June 2021of previous recommendations concerning the postponing scheduled surgery suggesting local adaptations of this delay if epidemic developments appear. Today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. Among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Polyclinique de Villeneuve Saint Georges

location_facility: CH Charleville Mézière - CH Intercommunal Nord Ardennes

location_facility: Hôpital E. Herriot - Hospices Civils de Lyon

location_facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)


title: A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.

summary: RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Hôpital Bicêtre - HdJ - Médecine interne

location_facility: Centre médico chirurgical Foch - Suresnes

location_facility: Hôpital Beaujon - Service de médecine interne

location_facility: Hôpital Lariboisière - Service de médecine interne A

location_facility: Hôpital Hôtel Dieu - Service d'immunologie clinique


title: Neoadjuvant and Adjuvant Ribociclib and Endocrine Therapy for Clinically High-risk Estrogen Receptor-positive (ER+) and HER2-negative (HER2-) Breast Cancer

acronym: RIBOLARIS

summary:
This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.

This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

lead_sponsor: SOLTI Breast Cancer Research Group

location_country: France Portugal Spain

location_facility: Sainte Catherine - Institut du Cancer Avignon Provence

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Départemental de Vendee

location_facility: Clinique Sainte Anne - Strasbourg Oncologie Libérale

location_facility: Centre Hospitalier Universitaire de Grenoble Alpes

location_facility: Hospital Universiatrio Clínico San Cecilio

location_facility: Complejo Asistencial Universitario de León

location_facility: Hôpital Franco Britanique Fondation Cognacq Jay

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Clinique Mutualiste de l'Estuaire - Groupe HGO

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Institut de cancérologie Strasbourg Europe - ICANS


title: Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study

summary:
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges.

Eligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail.

The retrospective data were collected in a paper CRF via the medical file of patient.

Post-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes.

Patient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.

ReferenceCitation: Churchill RS. Stemless shoulder arthroplasty: current status. J Shoulder Elbow Surg. 2014 Sep;23(9):1409-14. doi: 10.1016/j.jse.2014.05.005. Epub 2014 Jul 11. Review.

ReferenceCitation: Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90(6):1244-51. doi: 10.2106/JBJS.G.00775.

ReferenceCitation: De Wilde LF, Audenaert EA, Berghs BM. Shoulder prostheses treating cuff tear arthropathy: a comparative biomechanical study. J Orthop Res. 2004 Nov;22(6):1222-30.

ReferenceCitation: Frankle M, Levy JC, Pupello D, Siegal S, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. a minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:178-90.

ReferenceCitation: Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46.

ReferenceCitation: Hawi N, Magosch P, Tauber M, Lichtenberg S, Habermeyer P. Nine-year outcome after anatomic stemless shoulder prosthesis: clinical and radiologic results. J Shoulder Elbow Surg. 2017 Sep;26(9):1609-1615. doi: 10.1016/j.jse.2017.02.017. Epub 2017 Apr 11.

ReferenceCitation: Hawi N, Tauber M, Messina MJ, Habermeyer P, Martetschläger F. Anatomic stemless shoulder arthroplasty and related outcomes: a systematic review. BMC Musculoskelet Disord. 2016 Aug 30;17(1):376. doi: 10.1186/s12891-016-1235-0. Review.

ReferenceCitation: Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5. Review.

ReferenceCitation: Lugli T. Artificial shoulder joint by Péan (1893): the facts of an exceptional intervention and the prosthetic method. Clin Orthop Relat Res. 1978 Jun;(133):215-8.

ReferenceCitation: NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28.

ReferenceCitation: Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.

ReferenceCitation: Neer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982 Mar;64(3):319-37.

ReferenceCitation: Post M, Jablon M, Miller H, Singh M. Constrained total shoulder joint replacement: a critical review. Clin Orthop Relat Res. 1979 Oct;(144):135-50.

ipd_sharing_description: No plan to share IDP for this study

lead_sponsor: FX Solutions

location_country: France Monaco

location_facility:
Hôpital Privé Antony
Clinique Convert
CHU Jean MINJOZ
Hopital privé Sainte Marie
CHMS Chambéry
Clinique La Montagne
Clinique Saint Charles
Centre Hospitalier de Dieppe
Clinique Saint Léonard
Infirmerie Protestante
Centre Hospitalier Princesse Grace
Hopital Privé Claude Gallien
Clinique Jouvenet
CHI Poissy - St Germain en Laye
Clinique Bergouignan
Centre hospitalier Bourg en Bresse
Clinique de l'Occitanie
Centre Hospitalier de St Malo
Clinique Mutualiste la Sagesse
Clinique des Maussins


title: An ALFA 2101 Multicenter Randomized Phase II Study: CPX-351 Versus Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

summary: The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria)

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller

location_facility: Centre Hospitalier de Versailles, Site André Mignot

location_facility: Institut d'hématologie de Basse Normandie (IHBN)

location_facility: Centre Hospitalier Sud Francilien (CHSF)


acronym: DIAL

title: A Phase II-III Randomized Trial Evaluating Maintenance Pembrolizumab (± Pemetrexed) Until Progression Versus Observation (± Pemetrexed) After 6 Months of Platinum-based Doublet Chemotherapy Plus Pembrolizumab Induction Treatment in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

summary:
Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials.

The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.


title: Evaluation of the Efficacy of Donepezil in the Treatment of Oxaliplatin-induced Peripheral Neuropathy: Proof of Concept Study

acronym: DONEPEZOX

summary:
The use of oxaliplatin in the treatment of colorectal or pancreas cancer induces (>75% of patients) severe sensorimotor neuropathy decreasing the quality of life of cancer survivors. Today, no treatment remains univocal for these peripheral neuropathies. But preclinical works have demonstrated that donepezil (acetylcholinesterase inhibitor use for Alzheimer's disease) was able to prevent and treat neuropathic symptoms in oxaliplatin-treated rats.

Present study aims to assess the therapeutic efficacy of donepezil on oxaliplatin-induced peripheral neuropathy (OIPN) in cancer survivors. Bibliographic data suggests an antineuropathic effect of donepezil in human and animal models. In clinic, a study have shown in healthy volunteers that donepezil (associated with gabapentin) reduced the pain threshold (better than gabapentin alone) caused by stimulation of the sural nerve, without severe adverse effect. Similarly, two studies in patients with neuropathic pain demonstrated that donepezil increases analgesic effect of gabapentin. Finally, a case report demonstrated an analgesic effect of donepezil in painful Alzheimer's disease patients. In animals, several studies demonstrated that donepezil induces analgesic and neuroprotective effects. Recently, a preclinical study demonstrated that donepezil induced antineuropathic effect in diabetic mice with neuropathic pain. Research unit INSERM U1107 (partner of the DONEPEZOX study) demonstrated the antineuropathic effects of donepezil in several animal models of chemotherapy-induced peripheral neuropathies, and very recently, a study have confirmed these results with oxaliplatin and cisplatin. These clinical and preclinical data have thus highlighted the potential beneficial effect of donepezil on neuropathic symptoms, without any significant adverse effects. Therefore the hypothesis is that the use of donepezil could reduce the symptoms of OIPN, limit the decrease in quality of life and the appearance of comorbidities (anxiety/depression) in cancer survivors.

For this purpose, the investigators propose here a proof of concept, multicentre, phase II, randomised, double-blind, placebo-controlled clinical study. The primary objective will be the curative efficacy of donepezil on the severity of OIPN in patients who have completed oxaliplatin-based chemotherapy for the treatment of colorectal or pancreas cancer and have peripheral neuropathy of grade ≥2. This will be assessed using the EORTC QLQ-CIPN20 sensory scale. Our methodological choice to use the QLQ-CIPN20 as the primary endpoint will allow us to more accurately (and in a standardized manner) characterize neuropathic symptoms and assess the therapeutic effect of donepezil on these symptoms. In addition, as secondary objectives, we will study the effect of donepezil on neuropathic pain, the intensity of neuropathic symptoms, health-related quality of life, and the tolerance of donepezil.

The 80 patients required will be randomized (1:1) to receive either placebo or donepezil (5 mg daily for 4 weeks and then 10 mg daily for 12 weeks as a single dose and according to tolerance and efficacy). Patients will be followed for 1 month after the end of treatment to assess the OIPN. As a proof of concept study, responder rate will be assessed only for Donepezil arm (primary objective) and compared between each treatment arm (secondary objective) after a minimum of 12 weeks of treatment. A responder will be defined as a patient with a decrease of neuropathic grade according to CIPN20 sensory score compraed to baseline.

ReferenceCitation: Kerckhove N, Tougeron D, Lepage C, Pezet D, Le Malicot K, Pelkowski M, Pereira B, Balayssac D. Efficacy of donepezil for the treatment of oxaliplatin-induced peripheral neuropathy: DONEPEZOX, a protocol of a proof of concept, randomised, triple-blinded and multicentre trial. BMC Cancer. 2022 Jul 7;22(1):742. doi: 10.1186/s12885-022-09806-8.

location_facility: Groupe Hospitalier Saint Vincent - Clinique Saint Anne

location_facility: Groupe Hospitalier des Portes de Provence

location_facility: Institut de Cancérologie de Bourgogne - GRReCC


title: Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma RHU(M)M Random or H24 Urine in (Multiple) Myeloma

acronym: RHUMM

summary: The primary objective of the study is to evaluate at Day 1 Cycle 2, the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in patients with Multiple Myeloma.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: CH Bretagne Atlantique Vannes et Auray-P.Chubert


title: Randomized Phase III Trial in MMR Deficient Endometrial Cancer Patients Comparing Chemotherapy Alone Versus Dostarlimab in First Line Advanced/Metastatic Setting

acronym: DOMENICA

summary: Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.

location_facility: CHU Saint-Etienne - Pôle de Cancérologie

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon


title: Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie

summary: The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.

lead_sponsor: Humans Matter

location_facility:
DE VALENCE Cécile
MINIAC-FOURNIER Stéphanie
KRAYEM Mona
DE MUYNCK Solène
CARRIQUE Pascale
CARCEY-CADET Elise
EMERIAU Mathilde
RAFFIN LETHULLIER Virginie
CLAVIER-MARCOUX Laetitia
CASTERES Catherine
LEGENDRE Laure
MARTINELLI Karen
LEJOSNE Julie
PREVOST Adeline
CAMUS-BRUNEAU Anne
CONTESTI Véronique
NADAUD Stéphanie
BRESSON Raphaëlle
MAZERAN Anne-Cécile
LEFÈVRE Hélène
ZIMMERMAN Amélie
DESCENDRE Myriam
AÏT LEMKADEM Mimouna
RUBINI Diane
BOCCOGNANI Jordane
CHABERT Claire
PASQUIER Amélie
SHAW PERRIN Anne-Sophie
CALAIS Cécile
VERLOT-MORY Ludivine
CAILLY Gautier
CRABÉ Marion
BLANC Emilie
BOIS PARRIAUD Françoise
KALCK Christine
COURANT Sabrina
BOUJU Céline
KIS Nathalie
REVERSE Christelle
BERTHELOT Florence
FORTIER Anne
VIERLING Pauline
RIZK Joumana
LE BOURHIS Aurélie
VOLUET FROMENT Adeline
CHAUVET Clémence
LECLERC LE COADOU Rozenn
RAYNAUD LEGROS Caroline
VALLERY Théoline
TERRASSON Cécile
RICARD Pauline
DELOUS Thomas
JORDANIS Mélanie
BERNARD-DENIS Fabienne
Britt
SCHMITT Véronique
FRITSCH Colombine
LHUILLIER Françoise
LADOUL Marine
BERTHOLOM Anne-Marine
FLAMMANT Anne-Sophie
BERARD Marine
KOCHEL Jeanne-Marie
KOUASSI-PUJOL Marie
HOLLINGSHAUSEN Sophie
JOIRE Isabelle
CADALEN Hélène
BLONDE Manon
GOBÉ Valérie
PELLATON Aurélie
BIRAN Sandrine
GUILLERMOND Sandra


title: A Phase II Randomized, Open-Labelled, Multicenter Study of Safety & Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy as First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer

summary: This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.

location_facility: Centre Hospitalier de Villefranche-sur-Saône

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms

acronym: AVAJAK

summary:
Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases.

These diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status.

In terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events.

Despite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients/year.

All these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events.

At the present time, DOAC can be used in cancer populations according to International Society on Thrombosis and Haemostasis (ISTH) recommendations, except in patients with cancer at high bleeding risk (gastro-intestinal or genito-urinary cancers). Unfortunately, in trials evaluating DOAC in cancer patients, most patients have solid rather than hematologic cancers (generally less than 10% of the patients, mostly lymphoma or myeloma).

In cancer patients, DOAC are also highly efficient to reduce the incidence of thrombosis (-30 to 60%), but patients are exposed to a higher hemorrhagic risk, especially in digestive cancer patients.

In the cancer population, pathophysiology of both thrombotic and hemorrhagic events may be quite different between solid cancers and MPN. If MPN patients are also considered to be cancer patients in many countries, the pathophysiology of thrombosis is quite specific (hyperviscosity, platelet abnormalities, clonality, specific cytokines…) and they are exposed to a lower risk of digestive hemorrhages. It is thus difficult to extend findings from the "general cancer population" to MPN patients.

Unfortunately, only scarce, retrospective data regarding the use of DOAC in MPNs are available data.

We were the first to publish a "real-life" study about the use, the impact, and the risks in this population. In this local retrospective study, 25 patients with MPN were treated with DOAC for a median time of 2.1 years. We observed only one thrombosis (4%) and three major hemorrhages (12%, after trauma or unprepared surgery). Furthermore, we have compared the benefit/risk balance compared to patients treated with LDA without difference.

With the increasing evidences of efficacy and tolerance of DOAC in large cohorts of patients including cancer patients, with their proven efficacy on prevention of both arterial and venous thrombotic events and because of the absence of prospective trial using these drugs in MPN patients, we propose to study their potential benefit as primary thrombotic prevention in MPN.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Médipôle Hôpital Mutualiste Villeurbanne

location_facility: Institut de Cancérologie Lucien Neuwirth St-Priest-en-Jarez


title: Psychological Trauma and Resilience After ICU Stay in Patients Treated With Mechanical Ventilation for Severe Critical Illness: the Multicenter, Prospective, Observational RESIREA Study

acronym: RESIREA

summary: Critically ill patients experience a severe physical disease, associated with a psychotrauma, which may lead to post-traumatic stress disorder (17 to 30% of patients after critical illness) and persistent symptoms of anxiety and depression. RESIREA study will study psychodrama, resilience and factors associated with resilience in patients previously included in the NUTRIREA-3 randomized controlled trial designed to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding in a well-defined group of severely ill ICU patients requiring at least MV and vasoactive drugs.

lead_sponsor: Nantes University Hospital

location_facility:
Hôpital Edouard Herriot
CHU Amiens Picardie nord
CHU Angers
CH de Lens
CHU de Valenciennes
APHP - Hôpital Cochin
CHBA - Vannes Auray
CH de Bigorre
CH Angoulême
APHP - Hôpital Raymond Poincaré
CH de Béthune
CH Argenteuil
CHU Gabriel Montpided
CH Chartres Louis Pasteur
CH Dieppe
CHRU Bretonneau
CH Annecy Genevois
CHD Vendée
CH du Mans
CHU Jean Minjoz
CHU de Nantes
CHU Amiens Picardie sud
CHR- Roger Salengro


title: Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-line Complete Surgery

summary: Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.

location_facility: Sainte Catherine Institut du cancer Avignon-Provence

location_facility: CHU de Saint-Etienne - Pôle de Cancérologie

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

location_facility: CHU Grenoble-Alpes - Site Nord (La Tronche)

location_facility: HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

location_facility: Centre ONCOGARD - Institut de cancérologie du Gard

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon


title: A Randomized Phase I/ II Multicenter Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

summary: Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU Angers
Hôpital Cochin
CHR d'Orléans
CH Henri Duffaut d'Avignon
Centre Hospitalier de Mont de Marsan
Hôpital Avicenne
CHU Nantes - Hôtel Dieu
Hôpital Necker
Centre Hospitalier Lyon Sud
Hôpital Saint Vincent de Paul
Institut de Cancérologie de La Loire
CHU de Tours - Hôpital Bretonneau
Centre Hospitalier de Périgueux
CHU de Rennes - Hôpital Pontchaillou
CHU de Caen Côte de Nacre
Hôpital Saint Louis
CHRU de Limoges - Hôpital Dupuytren
Institut Paoli Calmettes
CHU de Bordeaux - Hôpital Haut-Lévêque
CHU de Nice - Hôpital Archet 1
CHU de Grenoble
CH Le Mans
CHU de Poitiers
CHRU Nancy - Hôpitaux de Brabois
CHU Amiens-Picardie
Hôpital Paul BROUSSE
CHU de Nîmes
Centre Henri Becquerel
Centre Hospitalier de la Côte Basque
Centre Hospitalier Victor Dupouy
CHU Toulouse - IUCT Oncopole


title: One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers

acronym: OEDIPE-CRT-P

summary: This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis

lead_sponsor: Biotronik SE & Co. KG

location_facility: GCS Centre de Cardiologie du Pays Basque


title: Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation

acronym: Week'ALR

summary:
Pain is a major problem in Intensive Care Unit (ICU). Adequate pain management not only means decreasing the pain intensity, but also improving the functionality and allowing the early mobilization that is a prerequisite for improving recovery and decreasing the risk of complications in ICU. The complex problems involved in pain, analgesic interventions, and outcome have been emphasized in several surveys over the past decades, but apparently with only small improvements, despite the existence of several guidelines for perioperative pain management.

Regional analgesia techniques (peripheral and neuraxial nerve blocks) have the potential to decrease the physiological stress response to trauma or surgery, reducing the possibility of surgical complications and improving the outcomes. Recent studies suggested that surgical and trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Also they may reduce the total amount of opioid analgesics necessary to achieve adequate pain control and the development of potentially dangerous side effects. The use of the regional anesthesia technique in the ICU, however, can, in part, be limited by the presence of hemodynamic instability, bleeding diathesis, and by the fear of the performing procedures potentially associated with significant side effects in heavily sedated patients.

Although regional anesthesia emerges as a new and very interesting player for pain management in ICU, today very few data exists about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU/stepdown units. The main objective of this study is to assess the use of RA for pain management both initiates in the operative room for surgical patients then transferred in ICU/stepdown units and performs directly by the practicians in ICU/stepdown units, in several french units.

location_facility:
HCL Centre des Grands Brulés
APHM la Timone
APHP Bichat
Centre Jean-Perrin
HCL Hôpital Sud
AHPH Saint-Antoine
CHU
CH
APHM Nord


title: Loco-regional Anaesthesia in Video or Robot-assisted Thoracic Pulmonary Surgery

acronym: ARTIST

summary:
Currently, there is no data on the part and type of Loco-regional Anaesthesia used for Video or Robot-assisted Thoracic Pulmonary Surgery.

The aim of this epidemiological study is to identify, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations, the proportion and type of Loco-regional Anaesthesia used in Video or Robot-assisted Thoracic Pulmonary Surgery within French teams.

location_facility: centre de Lutte Contre le Cancer Jean Perrin

location_facility: CHRU de Lille _Clinique Cardiothoracique et Vasculaire

location_facility: Clinique de l'Infirmerie Protestante de Lyon


title: Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study

acronym: BIOEXALK

summary:
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients.

BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study.

Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA).

For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon).

Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.

primary_purpose: Basic Science

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility: Hôpital d'Instruction des Armées Ste Anne

location_facility: Centre Hospitalier de Villefranche sur Saone

location_facility: Oncologie Institut du Cancer de Montpellier

location_facility: Centre Hospitalier Intercommunal de Créteil

intervention_type: Genetic


title: Observatory of Patients With Haemophilia B Treated by IdElvion®

acronym: OrPHEe

summary: OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.

lead_sponsor: CSL Behring

location_facility:
CHU Clermont-Ferrand
Hôpital Edouard Herriot
CHU Toulouse
CHRU Nancy
CHRU Besançon
CHU Rennes
CHU Nice
CHRU Lille
CHU Tours
Hôpital André Mignot - CH Versailles
CHU Rouen
CH Annecy Genevois
CHRU Strasbourg
CHU Nantes
CHU Bordeaux - Hôpital Pellegrin
Hôpital Simone Veil
Hôpital Necker Enfants Malades
CH du Mans
CHU Saint-Etienne
CHU Caen
CHU Montpellier
CHRU Brest
CHU Dijon
CRC-MHC Hôpital Kremlin Bicêtre


title: Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Metastatic Cancer in Response After 6 Months of Standard IO

acronym: MOIO

summary: Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_facility:
CHU Besançon
Centre Georges François Leclerc
Hôpital La Timone -APHM
CHU Henri Mondor
ICANS
Centre François Baclesse
Insitut Godinot
Centre Jean Perrin
Centre Antoine Lacassagne
Hôpital Pitié Salpêtrière
Clinique Sainte Catherine
CHU Bretonneau
Institut de cancérologie de l'Ouest
IUCT
Centre Hospitalier Intercommunal
CHU Poitiers
Hôpital Saint Louis
Hôpital Européen Georges Pompidou
Clinique Chenieux
Institut Curie
Hospices Civils de Lyon
Hôpital Foch
Centre Eugene Marquis
Centre Hospitalier de la Côte Basque