Saint Brieuc

Researchers are evaluating the safety, tolerability, and effectiveness of farletuzumab ecteribulin (MORAb-202), a drug that targets folate receptor alpha, in participants with certain tumor types including ovarian cancer, endometrial cancer, non-small cell lung carcinoma, and triple-negative breast cancer. The trial includes dose-escalation, dose-confirmation, and dose-optimization parts to determine safe doses and assess early signs of how well the drug works, alone or combined with lenvatinib. The study also explores the use of oral corticosteroids alongside the treatment and aims to identify the best treatment regimens for further testing. Participants receive farletuzumab ecteribulin through intravenous infusion, with some treatment plans including oral corticosteroids such as prednisone, prednisolone, or dexamethasone. In the dose-optimization phase, the drug is given alone or combined with oral lenvatinib. Treatment is given every 21 days, and the study includes multiple parts lasting up to approximately five years to find the recommended doses and evaluate safety and response. During the study, participants undergo regular assessments including scans, laboratory tests, and safety monitoring to track tumor response and side effects. Researchers measure tumor shrinkage, dose-limiting toxicities, serious adverse events, and overall safety from the start of treatment through follow-up periods. Participants are monitored for up to five years to observe treatment effects and long-term safety, with detailed evaluations during each treatment cycle and after treatment ends.

Researchers are studying the biological features of advanced ALK-rearranged non-small cell lung cancer (NSCLC) in patients treated with new generation tyrosine kinase inhibitors (TKIs) as their first therapy. This study is part of the national EXPLORE ALK cohort, a multi-center observational project in France, focusing on patients with this specific genetic alteration. The goal is to better understand the tumor biology and resistance mechanisms by analyzing samples from diagnosis through disease progression. The study collects tumor tissue samples at diagnosis and, when possible, at disease progression for RNA sequencing to identify ALK fusion partners, variants, and co-mutations. Blood samples are also taken at diagnosis, first tumor evaluation, and at progression to analyze circulating tumor DNA (ctDNA) using next-generation sequencing panels that detect mutations, fusions, and other genetic changes. These biological analyses are centralized at specialized centers such as the Léon Bérard Center and Rouen University Hospital. Patients are treated with approved ALK inhibitors like alectinib, brigatinib, lorlatinib, or entrectinib as part of their standard care. Participants will provide blood samples at multiple time points and, if possible, tumor biopsy samples for detailed genetic analysis. Researchers will monitor the progression-free survival from treatment start for up to 72 months. The study involves regular evaluations to assess tumor status and collect biological material to track genetic changes over time. Consent for sample collection and participation in the study is required, and patient data is managed within the national health system framework.

Lateral ankle sprains are a common injury leading to many emergency department visits daily in France. These sprains are classified into three grades based on severity, but only mild and severe sprains are clearly identified. The study aims to assess the recovery of quality of life three months after an ankle sprain in patients who visited the Saint-Brieuc emergency department, considering the type of follow-up care they received and the sprain's severity. Participants will complete the FAAM-ADL questionnaire, a validated self-assessment tool for foot and ankle function, first upon arrival at the emergency department based on their memory of their function before the injury. A follow-up FAAM-ADL questionnaire will be completed three months later by email or phone, focusing on their current function and quality of life. The study will also classify the sprain severity using clinical data recorded during the initial emergency visit. Throughout the study, researchers will compare the two questionnaire results to evaluate recovery relative to the participant's baseline function before injury. The study involves no surgical treatments and excludes those with recent lower limb injuries or fractures. The total participation includes the initial emergency visit and the three-month follow-up assessment to monitor treatment outcomes and quality of life changes after the sprain.

Researchers are investigating whether an immune response similar to organ transplant rejection plays a role in intrahepatic cholestasis of pregnancy (ICP), a condition affecting pregnant women. This observational prospective study aims to explore the potential link between ICP and chronic inflammation in the placenta, which could open doors for new immunomodulatory treatments. The study will include 322 pregnant women at the time of delivery, with 161 diagnosed with ICP and 161 without the condition as controls. Blood samples from both mothers and their newborns will be collected at delivery to measure biological markers related to inflammation, immune rejection, and blood vessel formation. Researchers will also analyze the placenta for signs of chronic inflammation and compare findings between the two groups. Participants will undergo blood testing and placental examination at delivery. The main outcome measured is the presence of chronic inflammation in the placenta. This comprehensive evaluation will help clarify the biological differences associated with ICP. The study focuses on adult women with singleton pregnancies and follows them through delivery to assess inflammatory processes and placental health.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Approximately 40% of patients who stay in intensive care develop muscle dysfunction, especially those admitted for sepsis. This muscle injury affects both limb and respiratory muscles, causing weakness that complicates weaning from mechanical ventilation. The loss of muscle mass can be rapid and severe, linked to the patient's illness severity, and leads to longer ICU stays, reduced physical function, and increased long-term mortality. Risk factors like immobility and poor nutritional support may be modifiable, but clear effective treatments have yet to be established. Participants receive standard ICU care without changes to early mobilization, physiotherapy, or nutrition. Their muscle condition is tracked over time through scheduled visits at inclusion, days 3, 7, 14, 21, 28, ICU discharge, and day 90. Muscle strength and function are assessed using non-invasive clinical tests, ultrasound imaging, electroneuromyography, and blood sampling to evaluate inflammation and organ function. After ICU discharge, participants' physical ability, cognitive function, mental health, and nutritional status are also monitored. Researchers measure muscle strength changes using the Medical Research Council sum score throughout the study period, which lasts up to 90 days. This comprehensive follow-up aims to better understand muscle changes in sepsis patients and improve care strategies.

Researchers are studying chronic myelomonocytic leukemia, a type of leukemia, by collecting biological samples and associated anonymized data. This non-interventional, prospective study aims to better understand the disease's development and progression over time, with follow-up averaging 15 years. The study includes patients at any stage of the disease, whether or not they are receiving treatment. During the study, blood samples will be collected as part of routine medical assessments or clinical trials. Standard samples include two 10 mL EDTA tubes, with an additional 10 mL dry tube for initial assessments. Depending on the research needs, some tubes may be replaced with heparinized or citrated tubes. Bone marrow samples will also be taken during scheduled myelograms, and in rare cases, tissue samples may be collected during surgical procedures with surgeon consultation. Participants will be involved through their routine medical care, with samples collected during scheduled assessments. Researchers will monitor the disease by analyzing these samples and associated data to understand the disease's pathophysiology. The study requires signed consent and allows participation regardless of disease stage or treatment status. The average study duration is about 15 years, allowing long-term observation and understanding of chronic myelomonocytic leukemia.

Researchers are studying acute hidrosadenitis by creating a group of patients to better understand its different clinical forms and phenotypes. This study aims to improve knowledge about the disease's natural history, identify severe forms, and explore environmental factors that may contribute to the disease becoming chronic. The study plans to follow participants for about three years to gather this information. This is an observational study without any interventional treatments involved. Participants diagnosed with acute hidrosadenitis are followed over time to collect data related to their condition. The study focuses on characterizing the disease to support the development of appropriate therapeutic approaches based on different phenotypes. Participants will be monitored throughout the study period with assessments aimed at describing disease progression and identifying various clinical types. Researchers will collect information on the severity and environmental influences related to the disease's chronic nature. The total participation time averages three years, during which data are gathered to help define suitable care and follow-up strategies.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the safety and effectiveness of vamifeport in adults diagnosed with hereditary hemochromatosis related to the homeostatic iron regulator gene (HFE-HH). This phase 2, randomized, double-blind, placebo-controlled study aims to assess how vamifeport treatment impacts liver iron levels measured by magnetic resonance imaging (MRI) in these participants. Participants will receive either oral vamifeport capsules or matching placebo capsules during the study. The trial is conducted across multiple centers and uses a parallel-group design. The study specifically examines changes in liver iron concentration over a 360-day period. During the study, participants will undergo MRI scans to measure liver iron concentration at the start and end of the 360-day treatment period. Researchers will monitor safety and collect data on iron overload markers such as transferrin saturation and serum ferritin. The total involvement time for participants includes screening and the one-year treatment and assessment period.