Le Havre

Researchers are evaluating the use of stereotactic radiotherapy SRT as a treatment strategy for patients with oligoprogressive metastatic renal cell carcinoma RCC who are already undergoing systemic therapies. This phase II study focuses on patients whose cancer has progressed in a limited number of sites despite ongoing treatment, aiming to control local tumors and delay the need for additional systemic therapies. The study builds on evidence that SRT can effectively target RCC metastases and may also stimulate the immune system when combined with immunotherapy. The study involves delivering high-dose stereotactic radiotherapy to metastatic sites showing progression in patients receiving systemic therapies such as targeted drugs or immunotherapy. Eligible patients have 1 to 3 progressing metastases in up to 2 organs, with lesions measuring 4 cm or less, and will continue their current systemic treatment while receiving SRT either concurrently or sequentially. This approach aims to locally control progressing tumors and potentially extend the effectiveness of ongoing therapy. Participants will undergo imaging assessments to confirm disease progression and measure tumor response, with follow-up visits to monitor tumor control and treatment side effects. Researchers will evaluate progression-free survival six months after randomization as the primary outcome, along with local and overall control rates and treatment-related adverse events. The study includes monitoring for safety and effectiveness up to 12 months post-treatment, with participants involvement lasting until at least one month after treatment completion.

Radiotherapy for breast cancer can cause arm lymphedema, which is swelling that may lead to long-term discomfort and affect quality of life. This clinical trial is designed to assess whether an artificial intelligence AI tool that predicts individual risk of arm lymphedema after radiotherapy can help patients and doctors make better treatment decisions. The trial includes women aged 18 or older with breast cancer needing regional lymph node radiotherapy after surgery, regardless of hormone receptor or tumor status. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk through a web app that explains risk factors and suggests measures like compression sleeves. In the control group, this risk information will not be shared. Both groups receive the same radiotherapy treatment they would normally have, with no changes to dose or technique. The AI tool is evaluated only for its impact on decision-making and outcomes. Throughout two years, participants will have regular check-ups to track treatment choices, side effects, shoulder movement, breast appearance, quality of life, and the accuracy of the AI tools predictions. Researchers will also monitor how well patients follow recommendations for using compression sleeves, as well as cancer recurrence and survival. Questionnaires and clinical exams will be conducted at baseline, during treatment, and at multiple follow-up points to gather detailed information.

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

Researchers are investigating muscle dysfunction in patients with COPD, focusing on the loss of muscle mass and strength in the lower limbs, especially the quadriceps. This loss is linked to poorer health outcomes and increased risk of early death. The study aims to assess simple and new measurement methods to better monitor muscle health in these patients, potentially improving their care and quality of life. Participants will take part in a pulmonary rehabilitation program during which their quadriceps muscle will be measured using a tape for thigh circumference perimetry and a new technique called ShearWave elastography that evaluates muscle stiffness. These measurements, along with assessments of muscle thickness, strength, lean body mass, exercise capacity, and quality of life, will be taken at the start and after completing five weeks of rehabilitation. Throughout the study, participants will undergo these evaluations twice to track changes during the rehabilitation. The main outcomes measured are quadriceps size and stiffness at the beginning and end of the program. Additional assessments include muscle strength, body composition, endurance tests, and questionnaires about health and quality of life. This information will help determine how well these measurement methods work for monitoring muscle status in COPD patients.

Pemphigus diseases are serious, chronic autoimmune conditions that cause blistering due to the immune system attacking certain skin proteins. The two main types studied here are pemphigus vulgaris and pemphigus foliaceus. Researchers are evaluating a new personalized maintenance therapy involving rituximab infusions guided by antibody levels to see if this approach can better prevent disease relapses compared to the standard treatment. This is a phase 4 randomized study conducted by the University Hospital, Rouen, building on previous rituximab trials that led to regulatory approvals. Participants in the trial will receive initial treatment with rituximab and oral prednisone following French guidelines, with rituximab given at Day 1, Day 14, Month 12, and Month 18. One group will receive this standard regimen, while the experimental group will have their treatment adapted based on anti-desmoglein antibody levels. Additional rituximab infusions may be given at Month 6 or later if antibody levels remain high or increase, with up to two extra infusions per year allowed during the study. During the study, participants will be regularly monitored through blood tests for antibody levels and blood cells every three months for up to 7.5 years. Researchers will assess the number of disease relapses, time to relapse, duration of remission, quality of life, and rituximab exposure. The study will also track the total dose of rituximab and record safety outcomes. This long follow-up aims to understand if personalized maintenance with rituximab can reduce relapses and the need for corticosteroid treatment.

This research aims to explore the quality of life of women who have undergone surgery for invasive breast cancer. It focuses on how their quality of life changes throughout their care journey, especially considering their access to supportive oncological care both within and outside the healthcare facility. The study is observational and involves women who speak French and are covered by social security. Participants are assessed using various quality of life questionnaires, including FACT-B and EORTC QLQ-C30, among others. Women are grouped based on whether they seek supportive oncological care or do not receive any such care. The study monitors these groups over a 12-month period to compare changes in quality of life. During the study, participants will complete several questionnaires related to their quality of life at regular intervals up to 12 months. Researchers will collect and analyze this information to understand the impact of supportive care on patients well-being. The study excludes women with metastatic or bilateral breast cancer, those with recent other cancers, or those unable to complete questionnaires or participate fully.

Brain metastases affect many cancer patients, causing severe symptoms and lowering quality of life, which impacts survival. Treatments include surgery, stereotactic radiosurgery SRS, and whole brain radiotherapy WBRT. SRS is often preferred as it targets tumors precisely and is less invasive than surgery, with good survival benefits for single or postoperative brain metastases. However, SRS can lead to late side effects like cerebral radio necrosis RN, which causes neurological symptoms and may require treatment. This randomized phase III trial evaluates adding bevacizumab to corticosteroids for patients with symptomatic RN to see if it improves symptoms better than corticosteroids alone.

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

Researchers are investigating a new way to diagnose injuries of the long biceps tendon LBT, a tendon prone to damage from repeated small injuries or trauma, which can cause chronic problems. The study focuses on creating a pre-operative score called the HASS score that combines clinical and imaging data to improve diagnosis. This is important because current clinical tests and imaging methods are often ineffective or unclear, leading to uncertain treatment decisions finalized only during surgery. The research involves developing and evaluating the HASS score as a diagnostic tool before surgery. This score aims to provide a reliable and reproducible method to identify LBT injuries, helping doctors better plan surgical treatments and avoid unnecessary procedures. The study collects clinical and paraclinical data from patients who have persistent shoulder pain and are candidates for surgical procedures like tenodesis or tenotomy. Participants will be involved in assessments that gather relevant clinical signs and imaging data to contribute to the HASS score. Researchers will measure the accuracy and usefulness of this score in diagnosing LBT injuries. The primary outcome is the HASS score itself, assessed shortly after data collection. This observational study helps improve surgical planning and patient information by providing clearer preoperative diagnostic tools.

This research evaluates the effect of preventive pain relief by injecting a local anesthetic called Ropivacaine before making a vaginal incision during a hysterectomy using the vNOTES approach. The study focuses on adult female patients aged 18 to 70 undergoing this surgery for benign conditions. The trial is randomized and double-blind, comparing Ropivacaine injection to a saline placebo to assess pain after surgery. Participants will be randomly assigned to one of two groups before surgery one group receives 20 mL of Ropivacaine injected as a paracervical block at four points, 3 mm deep into the vaginal cul-de-sac, three minutes before the vaginal incision, while the other group receives 20 mL of saline placebo. Both groups will have general anesthesia and receive the same standard pain relief during and after surgery. During the study, researchers will measure pain levels four hours after surgery using questionnaires including numerical rating scales and others related to sexual function and quality of life. Participants will be monitored for safety and treatment effects with consistent postoperative care. The overall participation will last through the surgery and immediate recovery, with pain assessment as the main outcome measure.