Besancon

Researchers are evaluating the quality of 3D hand models created using EOS imaging compared to the gold-standard computed tomography (CT) scans. The study focuses on patients who require CT scans of the hand or wrist, aiming to assess the accuracy and detail of the EOS imaging system for personalized hand model creation. Participants undergo EOS hand imaging, and their EOS images are directly compared with CT images to evaluate the model quality. The study does not involve drug treatments but uses these imaging devices to gather data for comparison. Participants will have both EOS and CT imaging performed, with data collected on Day 60. Researchers will analyze the imaging results to determine the quality of hand modelization provided by EOS imaging in comparison to CT scans. The total participation time is focused around the imaging and data collection at the scheduled time point.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This study aims to collect real-world medical data on the device's effectiveness and safety over a period of 12 and 36 months after implantation. The study is a multicenter, prospective, non-interventional follow-up involving urologists experienced with the device. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and treat male stress urinary incontinence caused by intrinsic sphincter deficiency. Participants receive the device through surgical implantation, and their progress is tracked during routine clinical visits. Follow-up visits occur around baseline (preoperative and implantation), between 1 and 3 months post-operation, and at 12 months. Afterward, annual questionnaires are mailed for two more years to continue monitoring. Participants are involved in routine clinical care with additional questionnaires to assess their condition. Researchers evaluate patient-reported improvement and monitor any adverse events at 12 months. The total study duration includes follow-up up to three years post-implantation, allowing long-term observation of device performance and safety in a real-world setting.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

Researchers are evaluating the experimental antibody COM701 in participants with relapsed platinum sensitive ovarian cancer (PSOC). This trial aims to find out if COM701, given as a maintenance treatment, can delay the progression of ovarian cancer, delay the need for new anti-cancer treatments, and to assess its safety. The study is part of an adaptive-platform trial with multiple sub-studies, focusing initially on COM701 alone compared to a placebo. Participants are randomly assigned in a 1:2 ratio to receive either a placebo or COM701 via intravenous infusion every 3 weeks. The trial includes a double-blind, randomized, placebo-controlled design for the first sub-study. Future sub-studies will explore COM701 combined with other anti-cancer drugs. During the study, participants will visit the clinic every three weeks for treatment and monitoring. Health checks include physical exams, vital signs, ECGs, blood and urine tests, and pregnancy tests if applicable. Disease response will be assessed with CT or MRI scans and tumor marker tests using tumor tissue samples. The primary measure is progression-free survival, tracking time from randomization until disease progression or death, assessed up to two years.

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are creating a national, prospective cohort to study children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The goal is to collect detailed data on patients treated in pediatric nephrology centers across France, Reunion Island, Mayotte, and eventually other French overseas territories. This structured follow-up aims to better understand the disease's characteristics and provide a foundation for future clinical trials. The study involves enrolling pediatric patients diagnosed with INS and systematically collecting clinical, biological, psychological, and social data. Biological samples such as blood, urine, hair, and nails will be gathered at disease onset before immunosuppressive treatment begins. Data will be recorded through medical records from hospital visits and consultations, supplemented by annual telephone interviews for patients without active disease. Quality of life, treatment adherence, and aesthetic impact questionnaires will also be collected and integrated into a secure database. Participants will be followed over at least two years, with data collected regularly by clinical research staff. This includes medical validation of clinical information, annual telephone follow-ups, and questionnaire assessments. The study's primary outcome is the number and characteristics of included cases over two years. This ongoing monitoring will support future nested studies and improve understanding of pediatric INS outcomes and management.

Researchers are studying bleximenib, an investigational drug taken orally, to find the best dose for treating acute leukemia and to evaluate its safety and effectiveness. In Phase 1, they aim to identify the recommended Phase 2 dose (RP2D) through a dose escalation and expansion process. Phase 2 will focus on assessing how well bleximenib works at the recommended dose in participants with relapsed or refractory acute leukemia, particularly those with specific genetic alterations in KMT2A, NPM1, or NUP98/NUP214. The study involves administering bleximenib orally and includes different participant groups based on age and disease status. Phase 1 includes pediatric participants aged 2 to less than 18 years and adults 18 years and older with relapsed or refractory acute leukemia who have limited treatment options. Phase 2 focuses on adults over 18 with relapsed or refractory acute myeloid leukemia harboring KMT2A or NPM1 mutations. The trial monitors participants for dose-limiting toxicities, adverse events, and treatment tolerability over periods lasting up to nearly five years. Participants will undergo evaluations of safety, including the number and severity of adverse events and dose-limiting toxicities during the first cycle. The effectiveness measure in Phase 2 is the rate of complete remission or remission with partial blood count recovery. Throughout the study, participants will be assessed using laboratory tests, performance status scales, and pregnancy tests as applicable. Safety monitoring and long-term follow-up will continue for up to 4 years and 9 months to fully evaluate treatment effects and tolerability.