Amiens

Cataracts cause clouding of the eye's lens, mostly due to aging, and surgery is the main treatment. The usual method, phacoemulsification, uses ultrasound to break up and remove the lens. A newer method, high-frequency pulsed vacuum technology, is being studied because it may be less invasive and cause less damage to the eye's delicate tissues, potentially leading to quicker recovery and fewer risks. This study compares the two techniques in patients with cataracts in both eyes who need surgery. Participants will have cataract surgery on both eyes using both techniques in a randomized order. One group will have their first eye operated on with phacoemulsification and the second eye with the pulsed vacuum method, while the other group will have the reverse order. The pulsed vacuum technology works by pulsing the vacuum to break up the cataract gently, maintaining eye stability and reducing turbulence and damage to endothelial cells. During the study, researchers will monitor the health of the cells lining the inside of the cornea using special microscopy 30 days after each surgery. Patients will undergo assessments to measure outcomes related to cell counts and recovery. The study aims to show the benefits of the pulsed vacuum technique compared to the traditional ultrasound method in cataract surgery.

Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

Research shows that women who experience interpersonal violence are at a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination in clinical forensic medicine units, which also offer initial psychological evaluations. However, many women do not attend follow-up appointments. This trial aims to evaluate the effectiveness of a case management algorithm using early phone contact compared to usual care on clinical outcomes after such consultations for female victims of violence. Participants in the intervention group, called VIGITRAUMA, will receive a phone call three weeks after their initial consultation, with the possibility of a second call. If contact is not made after the second call, a postcard will be sent. The control group will receive the standard follow-up care without additional phone contact. The study is a prospective, multicenter, open-label, randomized controlled clinical trial involving women victims of violence. Women enrolled will be evaluated via phone at 3 months, 6 months, and 12 months following their consultation to assess clinical outcomes related to PTSD and violence-related symptoms. The study monitors the effectiveness of early phone contact in improving these outcomes and reducing the risk of PTSD development among participants.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

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 evaluating EO2463, an innovative cancer peptide vaccine, alone and combined with lenalidomide and/or rituximab, in patients with indolent Non-Hodgkin Lymphoma (NHL), including follicular lymphoma and marginal zone lymphoma. The study aims to determine the recommended Phase 2 dose, safety, tolerability, immunogenicity, and preliminary effectiveness of EO2463. This is a global, multicenter Phase 1/2 trial targeting patients with relapsed, refractory, or newly diagnosed NHL with specific disease grades and characteristics. EO2463 will be given as multiple doses either as monotherapy or combined with lenalidomide, which is administered on days 1 to 21 of 4-week cycles, and/or multiple doses of rituximab. The study includes several cohorts based on patients' disease status and treatment history. Patients receive treatment following the assigned regimen to evaluate safety and preliminary response. The study observes participants for up to 24 months to assess adverse events, overall response, and complete response rates. Participants will undergo scheduled visits, laboratory tests, and other procedures to monitor their health and response to treatment. Researchers will measure adverse events continuously for up to 24 months and evaluate overall and complete response rates during this period. Patients must comply with all study visits and procedures, provide informed consent, and meet specific criteria such as radiologically measurable disease and HLA-A2 positivity. Safety monitoring includes laboratory assessments and evaluation of toxicities throughout the study duration.

Researchers are evaluating ELVN-001, a new drug, in adults with chronic myeloid leukemia (CML), including those with or without a specific T315I mutation. This early phase 1a/1b study aims to find the best dose of ELVN-001 for future studies by assessing its safety, tolerability, and how the body processes the drug. The study also looks at changes in a key leukemia marker called BCR-ABL1 to gather initial evidence of the drug's effect on CML. Participants will receive ELVN-001 orally once or twice daily. The trial includes a dose escalation period to identify recommended doses for further research. This first-in-human study will monitor patients closely to understand the safety profile and pharmacokinetics of ELVN-001. The drug is being tested in patients who have relapsed, are resistant, or cannot tolerate other tyrosine kinase inhibitors (TKIs). Throughout the study, participants will be monitored for adverse events, dose-limiting toxicities, and any significant lab or heart test abnormalities up to 28 days in phase 1a and for up to 3 years in phase 1b. Researchers will assess safety, tolerability, and leukemia markers regularly. The total duration of monitoring allows for a thorough evaluation of ELVN-001's effects and safety in adults with chronic phase CML.