Saint Brieuc

Researchers are studying farletuzumab ecteribulin MORAb-202, a folate receptor alpha-targeting antibody-drug conjugate, in participants with selected solid tumors including ovarian cancer, endometrial cancer, non-small cell lung carcinoma, and triple-negative breast cancer. The study aims to evaluate safety, tolerability, and determine recommended doses in early phases, then assess preliminary effectiveness and further safety in later phases. Various treatment regimens and combinations with lenvatinib are also being explored to optimize dosing. Participants receive farletuzumab ecteribulin intravenously every three weeks in 21-day cycles. Some groups receive additional oral corticosteroids after each dose or different infusion schedules within the cycle. In one part, ovarian cancer participants receive either farletuzumab ecteribulin alone or combined with oral lenvatinib. The study includes dose escalation, dose confirmation, and dose optimization parts with separate cohorts for specific tumor types and treatment regimens. During the study, participants undergo regular assessments including tumor imaging to measure response, laboratory tests, vital signs, and ECGs to monitor safety. Researchers track adverse events, dose-limiting toxicities, and pharmacokinetics of the study drug. Outcome measures include objective response rate, duration of response, progression-free survival, overall survival, and clinical benefit rates, with follow-up lasting up to approximately five years after treatment initiation.

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

Researchers are investigating the recovery of quality of life in adults who visit the emergency department for an ankle sprain. The study focuses on assessing how well participants regain their baseline quality of life three months after the injury. It also considers the severity of the sprain and the type of follow-up care received, such as visits to physicians or physiotherapists. Participants will complete the FAAM-ADL questionnaire, a self-assessment tool measuring foot and ankle functional ability, first when they arrive at the emergency department. A second assessment using the same questionnaire will be done three months later by email or phone. The severity of the ankle sprain will be determined by the physicians clinical evaluation at the initial visit. During the study, researchers will compare participants functional ability and quality of life before and three months after the injury. This comparison will help evaluate recovery progress. The study is observational, and participants will be monitored without receiving experimental treatments. The total participation involves the initial emergency visit and a follow-up assessment three months later.

This research aims to understand whether an immune process similar to allograft rejection causes intrahepatic cholestasis of pregnancy ICP. The study includes pregnant women with and without ICP to explore if immunomodulatory treatments might be helpful. It is an observational study conducted by the University Hospital, Brest, focused on inflammation in ICP. The study involves 322 pregnant women at delivery, divided into two groups 161 women diagnosed with ICP and 161 without ICP. Blood tests will be performed on both mothers and newborns to measure various biological markers related to inflammation, allograft rejection, and angiogenesis. Placental tissue will also be analyzed to check for chronic inflammation. Participants will provide blood samples and placenta at delivery for detailed analysis. Researchers will compare biological and placental markers between the ICP and non-ICP groups. The main outcome measured is the prevalence of placental chronic inflammation at delivery, alongside levels of biological factors involved in inflammation, rejection, and angiogenesis. The study will monitor these outcomes at delivery and conclude by June 2025.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

Researchers are studying muscle dysfunction that occurs in about 40% of patients during intensive care, especially those with sepsis. This muscle problem affects both limb and breathing muscles, leading to weakness and difficulty weaning off ventilators. The condition worsens with longer immobility and inadequate nutrition and is linked to longer ICU stays, lasting physical impairments, and higher long-term mortality. Participants receive standard ICU care without changes to early mobilization, physiotherapy, or nutrition. Their muscle condition is monitored over time through clinical tests, ultrasound, electromyography, and blood samples. Follow-up visits occur from enrollment through ICU discharge and up to 90 days after, assessing muscle strength, inflammation, organ function, physical autonomy, cognitive function, mood, and nutritional status. During the study, participants undergo muscle strength assessments like the Medical Research Council score and handgrip tests with electromyography. Ultrasound scans and electroneuromyography help evaluate muscle and diaphragm function. Blood tests monitor inflammation and organ dysfunction. At 90 days, functional tests such as a 6-minute walk and cognitive assessments are performed. The study aims to understand muscle changes in ICU patients with sepsis to inform future care improvements.

This observational study involves patients diagnosed with chronic myelomonocytic leukemia, a type of leukemia characterized by increased monocytes in the blood. The purpose is to better understand the diseases underlying mechanisms, with data collected over an average of 15 years. Biological samples and anonymized data will be gathered during routine care or clinical trials to support this research. The study is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Participants will have biological samples collected, including blood and bone marrow, during scheduled medical assessments. Blood samples include standard tubes and may vary based on research needs, while bone marrow samples are taken during routine myelograms. In exceptional cases, tissue samples may be collected during surgical procedures if agreed upon with the surgeon. These collections occur alongside usual medical care without additional interventions. Throughout the study, participants will undergo sample collections aligned with their medical visits and tests. Researchers will analyze these samples and associated anonymized data to study the diseases pathophysiology. Participation involves no investigational treatments, and the study will monitor participants for up to 15 years to gather long-term data. Safety and routine care continue as usual during this period.

Researchers are studying acute hidrosadenitis to better understand its different types or phenotypes. This is important because recognizing these subtypes can help tailor more suitable treatments and care. The study aims to define the natural history of the disease and identify environmental factors linked to its chronic form over an average period of three years. This is an observational study where no treatments or interventions are tested. Instead, patients diagnosed with acute hidrosadenitis are followed over time to observe their condition. The study collects detailed information about the clinical forms of the disease and tracks how it progresses in patients. Participants will be monitored for about three years during which researchers will record data about their disease severity, clinical characteristics, and environmental exposures. The main outcomes measured include the different clinical forms of hidrosadenitis and factors that may influence chronic disease development. There is no specific treatment given rather, the study observes patients to gather valuable information for future care approaches.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating vamifeport in adults with homeostatic iron regulator gene-related hereditary hemochromatosis HFE-HH, a condition characterized by iron overload. This phase 2, multicenter, randomized, placebo-controlled, double-blind study aims to assess the effect of vamifeport on liver iron concentration using magnetic resonance imaging MRI. The study focuses on adults with confirmed HFE-HH and iron overload to explore the potential impact of the treatment. Participants are randomly assigned to receive either a low dose or a high dose of vamifeport, or a placebo, all administered orally twice daily up to 360 days. The study compares these three groups over this treatment period to evaluate the treatments effect on liver iron levels. The study includes careful monitoring and assessment of safety and efficacy throughout the treatment duration. During the trial, participants undergo regular assessments including MRI scans to measure liver iron concentration at baseline and day 360. Safety is monitored by tracking adverse events, laboratory tests, and electrocardiograms up to day 390. Additional evaluations include measurements of transferrin saturation, serum ferritin, joint pain, fatigue, and quality of life questionnaires. Blood samples are collected to measure vamifeport concentrations at specific time points. Participants are followed for a total of about 13 months, including treatment and safety monitoring periods.