Beauvais

Researchers are investigating metastatic colorectal cancer mCRC patients who have a specific genetic change called the BRAFV600E mutation. This rare subtype of mCRC often shows poor response to current treatments and has a generally poor outlook. The study aims to collect detailed clinical data and biological samples to better understand this condition, including how patients respond to treatments and what factors predict their survival. It focuses on real-world treatment outcomes and biological markers that might influence therapy choices and resistance. Participants will provide blood samples at multiple times during their treatment, including before and during the first three treatment cycles, at 3 and 6 months after starting each treatment line, and when disease progression occurs following certain therapies. The study gathers up to 390 mL of blood per participant over time to analyze circulating tumor DNA and immune environment factors. This observational approach will help researchers identify biomarkers related to treatment response and disease progression. During the study, participants clinical progress and survival will be tracked for up to five years. Researchers will review overall survival from diagnosis to death and assess how prognostic markers relate to progression-free survival and response to treatments. The study involves collecting tumor tissue samples and blood tests, along with routine follow-up visits. All data collected will contribute to understanding BRAFV600E mCRC and improving future treatment strategies.

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Researchers are evaluating the impact of a brief motivational intervention BMI delivered by pharmacists to help reduce the use of benzodiazepines and related drugs BZDZ in adults who have been taking these medications long-term at least 6 months. The study aims to see if this intervention can lower the daily dose of these drugs after 6 months without causing worsening of anxiety or sleep disorders, compared to usual pharmacy dispensing practices. This research takes place in the context of increasing prescriptions and concerns about prolonged use of BZDZ, which carry risks and potential adverse effects. Participants will either receive the BMI, which involves identification and a motivational approach that uses patients psychosocial skills and supporting tools to reduce BZDZ use, or continue with the standard practice of dispensing these medications in pharmacies. The intervention targets adults with chronic use of BZDZ, aiming for a practical and scalable method that pharmacists can apply during routine care. The study is randomized and does not use blinding. During the study, participants will be monitored over 6 and 12 months to assess changes in daily BZDZ doses, complete cessation rates, anxiety, depressive symptoms, insomnia severity, misuse, and any adverse events. Questionnaires and clinical evaluations will be used to measure outcomes at several points, including 3, 6, 9, and 12 months. The goal is to understand both the reduction in drug use and the clinical effects on patients symptoms and safety throughout the follow-up period.

Researchers are evaluating the best way to set mechanical ventilators for patients with acute respiratory distress syndrome ARDS, including those with COVID-19 and non-COVID-19 ARDS. This multicenter randomized controlled trial uses an adaptive design to compare ventilation strategies based on respiratory mechanics, aiming to reduce mortality 60 days after treatment begins. ARDS causes severe lung inflammation that makes ventilation challenging and can lead to ventilator-induced lung injury VILI. The trial includes two groups one receiving standard ventilation care following existing guidelines, and the other receiving individualized ventilation settings based on bedside measurements of lung recruitability and breathing effort. The experimental group undergoes specific maneuvers to assess airway closure and recruitability to set ventilator parameters such as tidal volume and positive end-expiratory pressure PEEP. Both groups receive volume control ventilation, with adjustments made as patients begin spontaneous breathing. Participants will be closely monitored during their ICU stay, with assessments including duration of ventilation, ICU and hospital stay length, organ dysfunction, barotrauma, and mortality at several time points up to 60 days. The main outcome measured is all-cause mortality at 60 days. Data collection, analysis, and patient management follow a shared protocol across both COVID-19 and non-COVID-19 patient groups, with safety and effectiveness monitored throughout the study period.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

This research aims to evaluate the use of sildenafil for erectile rehabilitation in men treated with neoadjuvant radiotherapy and proctectomy for rectal cancer. The study focuses on preventing long-term erectile dysfunction, a common complication after surgery and radiotherapy, which affects quality of life. The mechanisms causing erectile dysfunction include nerve injury during surgery and vascular damage from radiotherapy, leading to tissue changes and fibrosis that may become permanent without early intervention. Participants are randomly assigned to receive either sildenafil 50 mg daily or a placebo for 10 months, starting 30 days after surgery. The study compares these two groups to assess the potential benefits of early erectile rehabilitation. The trial uses a triple-blind design and follows patients over a year postoperatively to monitor erectile function and other health outcomes. During the study, participants undergo regular evaluations at baseline, 1, 3, 6, 9, and 12 months after surgery. Assessments include erectile function scores, quality of life, bowel function, psychological support, treatment adherence, and monitoring for adverse events. The primary outcome is the patients erectile response 12 months after surgery, with ongoing safety and effectiveness evaluations throughout the study period.

This research aims to determine if giving chemotherapy before surgery neoadjuvant chemotherapy can improve treatment outcomes for patients with non-metastatic obstructive colon cancer OCC who have had a colostomy to relieve obstruction. The study focuses on whether this approach increases the number of patients who complete the full recommended treatment, including surgery and chemotherapy, potentially improving prognosis by reducing tumor size and treating hidden cancer spread. This is a randomized phase III trial assessing this treatment strategy in patients with microsatellite stable MSS or proficient mismatch repair pMMR OCC. Participants will be randomly assigned to one of two groups. One group receives a diverting stoma followed by colectomy surgery and possibly adjuvant chemotherapy based on tumor stage and risk factors. The other group receives neoadjuvant chemotherapy with CAPOX or FOLFOX regimens for about three months, followed by surgery and potentially adjuvant chemotherapy depending on tumor analysis. Surgery is scheduled within days after randomization or chemotherapy completion, with treatments tailored by cancer stage and pathological features. During the trial, participants will undergo clinical assessments, imaging, and laboratory tests before and after treatments. Researchers will monitor treatment completion rates, surgical quality, adverse events, morbidity, mortality, and quality of life using questionnaires over 36 months. The primary outcome is the success of completing the full curative treatment sequence. Safety and effectiveness of neoadjuvant chemotherapy, along with surgical outcomes, will be evaluated to determine if this strategy improves 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 post-operative radiochemotherapy. This treatment is challenging due to recent surgery, hospitalization, weight loss, and difficulty in feeding during radiotherapy. The study aims to improve treatment completion rates and patient outcomes by providing a harmonized nutritional and supportive care strategy. Participants in the experimental group will receive early consultations with a nutritionist, pain specialist, and social worker at inclusion. During radiotherapy preparation, weekly visits with a pain nurse and dietician are planned. Throughout radiotherapy, patients will have daily weight checks, nutritional assessments, and weekly consultations with a pain nurse and dietician, then twice monthly follow-ups for three months post-treatment. The control group will receive standard care and monitoring. During the study, researchers will monitor weight loss from inclusion to three months post-treatment as the primary outcome. Secondary outcomes include overall and progression-free survival at 18 months, treatment completion rates, use of strong pain medications, average weight loss at 18 months, and a cost-utility analysis of the management approach. Participants will be followed for 18 months to assess these measures and support will be provided throughout the study period.