Le Havre

Researchers are studying metastatic renal cell carcinoma (RCC), a type of kidney cancer that spreads to other parts of the body, affecting many patients annually in France. This study focuses on patients with oligoprogressive disease, where only a few metastatic sites (1 to 3) show progression while the rest remain controlled under ongoing systemic treatments like targeted therapies or immunotherapy. The goal is to evaluate stereotactic radiotherapy (SRT) as a focused treatment to control these progressing sites and potentially delay the need for changing systemic therapies. The study involves delivering stereotactic radiotherapy, which uses high doses of radiation in one or a few sessions to target metastatic sites specifically. Patients with up to three progressive metastases eligible for SRT will receive this treatment concurrently or sequentially alongside their current systemic therapy. This approach aims to control tumor growth locally and possibly stimulate a broader immune response. The trial is a Phase II study, assessing this treatment strategy in patients receiving first or second-line systemic therapies. Participants will undergo imaging scans to confirm disease progression and lesion sizes, with follow-up assessments to monitor progression-free survival six months after randomization. Researchers will evaluate how well the targeted radiotherapy controls tumor sites and delays further disease progression. Patients will be closely monitored for treatment effects, ability to continue systemic therapy, and overall safety throughout the study period.

Radiotherapy after breast cancer surgery can cause arm lymphedema, which is swelling that may lead to long-term discomfort and impact quality of life. This research aims to evaluate whether using an artificial intelligence (AI) tool to predict each patient's risk of developing arm lymphedema can help patients and doctors make better treatment decisions. The study involves women aged 18 years or older with unilateral breast cancer who need regional lymph node irradiation after surgery, regardless of hormone receptor status or tumor grade. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk of developing arm lymphedema and use this information to guide treatment choices. In the control group, the risk prediction will not be shared. All participants will receive radiotherapy as they normally would, and the only difference is whether they are informed about their predicted risk using the XAINET AI tool presented via a web app. During the two-year follow-up, researchers will monitor how sharing risk information affects treatment decisions, the occurrence of side effects like arm lymphedema, the accuracy of the AI tool, patients' quality of life, and adherence to wearing compression sleeves. They will also track cancer recurrence and survival outcomes. Patients will have scheduled visits and assessments to collect this information throughout the study.

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

Muscle dysfunction is a common issue in people with COPD, involving loss of muscle mass and strength, especially in the legs. This condition significantly affects patients' functional abilities, quality of life, and survival. The study aims to evaluate simple and new methods to better monitor quadriceps muscle function in COPD patients, hoping to improve disease management. Participants will take part in a pulmonary rehabilitation program where their quadriceps muscle will be assessed using tape measurements of thigh circumference (perimetry) and ShearWave elastography, a technique measuring muscle stiffness. These assessments will be done on the first day and again after five weeks at the end of the rehabilitation program. Additional tests including muscle thickness, strength, body composition, endurance, and a questionnaire about anxiety and depression will also be performed. During the study, researchers will closely monitor changes in muscle size and stiffness to understand the value of these measurements for COPD care. Participants will undergo physical tests and complete questionnaires twice, allowing comparison before and after rehabilitation. The study focuses on gathering reliable data that could help future monitoring and treatment of muscle problems in COPD over a five-week period.

Researchers are evaluating a personalized maintenance therapy for pemphigus, a life-threatening chronic autoimmune blistering disease affecting the skin and mucous membranes. This study focuses on comparing this personalized approach, which uses anti-desmoglein antibody levels as biomarkers, with the standard treatment involving rituximab combined with corticosteroids. The trial builds upon previous successful studies that supported rituximab's approval for pemphigus treatment by the FDA and EMA. Patients in the personalized maintenance group receive additional rituximab infusions based on their antibody levels and disease activity, aiming to prevent relapses and reduce the need for corticosteroids. The standard treatment consists of two doses of rituximab combined with oral corticosteroids, given after a clinical relapse. The study monitors antibody levels and disease activity over time to guide treatment decisions. Participants will undergo regular assessments, including clinical evaluations and antibody measurements, over a 7.5-year period to track the number of disease relapses per patient-year. The study also involves monitoring safety, treatment adherence, and the effectiveness of the personalized treatment strategy compared to the standard approach. Participation includes vaccination requirements and compliance with study protocols to ensure safety and reliable results.

This research aims to understand how the quality of life changes for women who have undergone surgery for breast cancer. It focuses on their entire care journey, especially considering their access to supportive oncological care both within and outside the healthcare facility. The study specifically involves women diagnosed with invasive breast cancer and looks to explore factors affecting their well-being after surgery. Participants in the study will complete several quality of life questionnaires, including FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, and QSSS-C. These questionnaires help assess various aspects of their physical, emotional, and social health during their treatment and recovery process. The study compares how access to additional supportive care affects these quality of life measures. Women taking part will be monitored over a 12-month period during which they will regularly complete the questionnaires. Researchers will evaluate their responses to understand changes in quality of life over time. The study also ensures that participants meet certain health and language requirements and that they can complete the questionnaires, while excluding those with conditions or circumstances that might interfere with treatment or data collection.

Brain metastases affect a significant number of cancer patients and can cause severe symptoms that reduce quality of life and survival. Common treatments include surgery, stereotactic radiosurgery (SRS), and whole brain radiotherapy (WBRT). SRS is often preferred for patients with single or operable brain metastases due to its effectiveness and lower invasiveness. However, a common late side effect of SRS is cerebral radionecrosis (RN), a condition involving brain tissue damage that can cause neurological symptoms and often requires treatment with corticosteroids. Some patients become resistant or dependent on corticosteroids, and bevacizumab, an anti-VEGF drug, has shown potential but needs further study. This phase III randomized trial is testing whether adding bevacizumab to standard corticosteroid therapy improves symptoms and reduces corticosteroid use in patients with symptomatic RN after brain radiotherapy. Participants will be randomly assigned to receive either bevacizumab or a placebo in addition to corticosteroids. RN diagnosis will rely on clinical symptoms and multimodal imaging, including MRI and nuclear medicine scans. The study will monitor patients over three months to evaluate the effects of treatment. During the study, participants will be assessed for changes in corticosteroid use and neurological symptoms at 90 days. Researchers will also evaluate side effects, quality of life, patient-reported and clinician-reported outcomes, imaging changes, and the duration of treatment response. An additional study will analyze how initial imaging and biological markers relate to treatment success with bevacizumab. The trial aims to provide clearer evidence on the benefits and safety of bevacizumab combined with corticosteroids for treating brain radionecrosis.

Researchers are studying gene variants of uncertain significance (VUS) found in genes linked to hereditary breast, ovarian, and other cancers. The goal is to better classify these VUS using data from a large French genetic database to improve genetic counseling and help guide clinical decisions, including preventive surgeries. The study originally focused on BRCA1 and BRCA2 genes but now includes multiple cancer-related genes identified through ongoing genetic testing in French families. Participants include index cases who carry specific VUS classified as uncertain or likely causal, along with their selected family members. Saliva samples are collected from these relatives to test for the presence of the variants. The study uses co-segregation analysis, which examines how the variant tracks with disease within families, applying a Bayesian model alongside other genetic and clinical data to estimate the likelihood that a variant causes cancer. Participants provide informed consent and saliva samples for genetic testing. Researchers compile data from multiple families to strengthen the classification of variants. The primary outcome is to perform co-segregation analysis over a period of up to 15 years. This long-term study aims to refine the clinical relevance of genetic variants to support personalized cancer risk assessment and counseling for affected families.

The long biceps tendon (LBT) is vulnerable to damage from repeated small injuries or trauma, which can cause chronic problems. Diagnosing LBT injuries before surgery is challenging because symptoms often overlap with other shoulder conditions, and current tests like ultrasound and MRI are not always reliable. This study aims to develop a pre-operative score called the HASS score that combines clinical and paraclinical information to help diagnose LBT injuries more accurately and improve treatment decisions. Participants will be evaluated using the new HASS score, which is designed to provide a reliable diagnosis of LBT injuries before surgery. The score incorporates various clinical and imaging data to overcome limitations of existing tests. This approach is intended to better guide surgical planning and reduce unnecessary procedures, especially for lesions not visible during arthroscopy. During the study, patients will be assessed based on their clinical signs and imaging results to calculate the HASS score. Researchers will measure the score's accuracy in diagnosing LBT lesions by comparing it to findings during surgery. The primary outcome is the HASS score measured one day after assessment. This process aims to improve preoperative diagnosis and surgical management of LBT disorders.

Researchers are studying the effect of a local anesthetic injection before vaginal incision in women undergoing hysterectomy using the vNOTES approach. This phase 3 randomized, double-blind trial compares the use of Ropivacaine, a local anesthetic, versus a saline placebo to evaluate preventive pain relief during surgery. The aim is to assess pain levels after surgery in adult female patients aged 18 to 70 undergoing hysterectomy for benign conditions. Participants are randomly assigned to one of two groups before surgery. The experienced group receives 20 mL of Ropivacaine (150 mg total) injected at four points around the vaginal area, three minutes before the vaginal incision, while under general anesthesia. The control group receives 20 mL of saline (placebo) injections at the same time and sites. Both groups receive the same standard pain relief medications during and after surgery. During the study, participants complete pain rating questionnaires and other assessments such as the FSFI, SF12, and DN4 to monitor pain and recovery. Pain is specifically measured four hours after surgery. The study also monitors safety and side effects related to the injections and anesthesia. Participation includes follow-up assessments to evaluate outcomes related to pain and overall recovery after the hysterectomy procedure.