Beauvais

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

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 studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are studying the impact of a brief motivational intervention (BMI) conducted by pharmacists to help reduce the use of benzodiazepines and related drugs (BZD/Z) in adults who have been using these medications long-term. The study addresses the growing use and prolonged prescriptions of these drugs in France, where long-term use often exceeds recommended limits and can lead to adverse effects. The goal is to see if this short-term, pharmacy-based approach can support patients in safely reducing their medication dose without worsening anxiety or sleep disorder symptoms. Participants will be divided into groups receiving either the brief motivational intervention or usual pharmacy dispensing practices. The intervention involves pharmacists identifying patients on long-term BZD/Z treatment and applying motivational techniques to encourage dose reduction. The study focuses on adults with continuous BZD/Z use for at least six months. The researchers will evaluate changes in daily drug dose and monitor any clinical worsening over a six-month period. Throughout the study, participants will be assessed for medication use and symptom changes related to anxiety and sleep disorders. Researchers will collect data on the daily dose of BZD/Z and track any clinical worsening at six months. The study includes informed consent, patient understanding assessments, and affiliation with the French social security system. The outcomes will help determine the feasibility and impact of pharmacist-led interventions for deprescribing BZD/Z in adults.

Researchers are evaluating a new way to set mechanical ventilators for patients with acute respiratory distress syndrome (ARDS) to reduce death rates within 60 days. This trial includes adults with moderate to severe ARDS, whether caused by COVID-19 or other reasons, and compares a ventilation method based on lung mechanics to standard care. ARDS affects lung function severely, making ventilation challenging, and this study aims to find the best bedside ventilation approach to avoid further lung injury. The study has two groups: one where ventilator settings are personalized using bedside respiratory mechanics measurements like recruitability and airway closure, adjusting pressures to protect the lungs; and a control group receiving standard ventilation based on oxygen levels and standard protocols. Ventilation settings are carefully adjusted during the study, including volume control at specific levels and monitoring spontaneous breathing efforts. The design includes two sub-studies with shared procedures for both COVID-19 and non-COVID-19 ARDS patients. Participants will be monitored for 60 days to measure overall mortality. During the study, patients receive detailed assessments including breathing mechanics, oxygen levels, and ventilator parameters. Researchers track lung function and adjust treatments accordingly while ensuring safety limits. The trial collects data on how well the ventilation strategies protect the lungs and support recovery over this period.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are evaluating the effectiveness of early erectile rehabilitation using Sildenafil in men who have undergone neoadjuvant radiotherapy followed by proctectomy for rectal cancer. Erectile dysfunction is a common complication after these treatments due to nerve damage and vascular injury, significantly impacting quality of life. This phase 3 study aims to prevent long-term erectile dysfunction by starting treatment 30 days after surgery and continuing for 10 months. Participants are randomly assigned to receive either Sildenafil (50 mg daily) or a placebo, both started 30 days after surgery and taken daily for 10 months. The study compares these two groups to assess whether Sildenafil can help maintain erectile function postoperatively. The treatment aims to promote nocturnal erections to oxygenate erectile tissue and prevent fibrosis, which can cause permanent dysfunction. Throughout the study, researchers will monitor participants for erectile function response at 12 months after surgery. Assessments include regular evaluations of sexual activity and function, ensuring patients meet criteria such as having a regular sexual partner and normal preoperative erectile function. Safety and adherence to treatment are tracked, with follow-up extending over a year to measure long-term outcomes and any adverse effects.

Researchers are investigating whether giving chemotherapy before surgery (neoadjuvant chemotherapy) can improve outcomes for patients with obstructive colon cancer treated initially by colostomy. The study focuses on patients with non-metastatic colon cancer who have had their bowel obstruction relieved by a stoma. The goal is to increase the number of patients who successfully complete the full recommended treatment, which may include surgery and chemotherapy, potentially improving their prognosis by reducing tumor size and treating micrometastases. Participants will receive neoadjuvant chemotherapy using the FOLFOX or CAPOX regimens after colostomy placement and before colectomy. Depending on tumor analysis after surgery, additional adjuvant chemotherapy may be given. The treatment strategy follows French oncological guidelines tailored by tumor stage and risk factors. This phase III randomized trial compares the new approach against standard treatment to evaluate feasibility, tolerance, and efficacy. Throughout the study, patients will be closely monitored for treatment response and safety. Clinical evaluations, imaging scans, and laboratory tests will assess tumor status and overall health. The primary outcome is the success of a complete curative treatment sequence over 36 months. Researchers will also evaluate the ability to tolerate the full treatment plan and long-term outcomes, aiming to improve the standard care for obstructive colon cancer.

Researchers are evaluating an optimized early management approach for patients with squamous cell carcinoma of the head and neck who are undergoing curative post-operative radiochemotherapy with cisplatin. This treatment is challenging due to recent surgery, weight loss, and feeding difficulties during radiochemotherapy, which often causes radiomucositis. The study aims to improve treatment completion rates and potentially increase overall survival by enhancing nutritional and supportive care during therapy. The intervention includes early consultations with a nutritionist, pain specialist, and social worker at the start of the study. During radiotherapy preparation, patients receive weekly consultations with a pain nurse and dietician. Throughout radiotherapy, patients are weighed daily, have their nutritional needs assessed, and continue weekly consultations with pain and dietetic support. After radiotherapy, these consultations occur twice a month up to three months post-treatment. Participants will be closely monitored through weight measurements and assessments of nutritional status. Researchers will evaluate the impact of this multimodal management on weight loss from the start until three months after treatment. The study involves ongoing support and safety monitoring to improve treatment tolerance and adherence, with total participation covering this treatment and follow-up period.