Bayeux

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.

Chronic pain affects a significant portion of adults and elderly individuals worldwide and presents major societal and economic challenges, including reduced work ability and high healthcare costs. Current treatments often have limited success and notable side effects, leading to a need for better therapeutic options and care organization. This research aims to create a French e-cohort to enable personalized monitoring and detailed characterization of chronic pain patients using innovative digital tools. Participants will use the eDOL system, a digital health tool that includes a smartphone app for patients and a web platform for healthcare providers in pain clinics. This system collects a wide range of data through repeatable questionnaires, weekly symptom tracking, therapeutic education, and a conversational agent. The study will enroll a minimum of 5000 patients from 20 pain clinics and follow them for 24 months to gather comprehensive real-life information. Throughout the study, data on pain, related conditions, sleep, activity, emotional factors, demographics, and treatments will be collected and linked to French health insurance records to assess care usage and comorbidities. Researchers will analyze these data over five years to better understand chronic pain and its impacts. Participants will regularly complete assessments via the eDOL app, enabling ongoing monitoring and personalized follow-up in real-world settings.

Researchers are evaluating the impact of digital monitoring of self-reported symptoms on managing treatment adjustments in patients with advanced clear-cell renal cell carcinoma (RCC). This study focuses on patients receiving the combination of cabozantinib and nivolumab, aiming to observe how digital symptom tracking influences treatment decisions in real-life conditions during the first 3 months of therapy. This is a Phase 4 study involving patients with advanced or metastatic RCC who have not received prior systemic treatment for this disease. Participants receive cabozantinib orally at 40 mg once daily and nivolumab intravenously at 240 mg every 2 weeks, following approved labeling indications. Throughout the combined treatment period, a digital monitoring system collects weekly patient-reported data on treatment tolerance and symptoms. This digital approach supports real-time tracking of how patients tolerate the medications and helps inform treatment management. During the study, participants regularly provide self-reported symptom data via the digital system. Researchers monitor treatment adjustments within the initial 3 months of combined therapy as the primary outcome. Patients' adherence to treatment, symptom reports, and any changes in treatment management are closely observed. The study includes safety and tolerability assessments alongside the digital monitoring to evaluate the real-world application of this combined therapy and symptom tracking approach.

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

Researchers are evaluating the effects of Qiseng®, a dietary supplement made from American ginseng extract combined with vitamin C from Camu Camu berries, on fatigue in female patients treated for localized breast or gynecological cancer. This multicenter randomized, placebo-controlled, double-blind trial aims to assess the safety and effectiveness of Qiseng® in reducing cancer-related fatigue experienced after treatment. Participants will be randomly assigned to receive either Qiseng® or a placebo, each given as two capsules daily for 8 weeks. The study involves a comparison between these two groups to monitor changes in fatigue levels over the treatment period. During the trial, researchers will assess participants' fatigue scores using a visual scale at one week and four weeks after finishing the 8-week treatment. Participants will be monitored for safety and adherence throughout the study, which includes follow-up assessments to measure the change in fatigue associated with the intervention.

Researchers are evaluating the performance and safety of a mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert in people aged 12 years and older who have acute rhinitis with nasal obstruction. This study focuses on cases caused by infectious episodes like rhynopharyngitis (cold), rhinosinusitis, or non-infectious episodes such as allergic rhinitis. The purpose is to assess how well the spray works and its safety over a 7-day period. Participants will use the mechanical decongestant seawater spray enriched with essential oils, and the study will track its effect on nasal obstruction symptoms. The main focus is on measuring the spray's performance from the start of treatment (Day 0) to Day 3. There are no other treatments or comparator groups mentioned. During the study, participants will complete questionnaires to provide information about their symptoms and experience. Researchers will monitor their nasal obstruction and any reactions to the spray, ensuring safety throughout. The total study duration for each participant is 7 days, with key assessments focused on the three-day mark after starting the spray.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

Researchers are evaluating the plasma levels of various multikinase inhibitors in patients with advanced digestive cancers, including gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), and pancreatic neuroendocrine tumor (pNET). This phase IV, national, multicenter, open-label study aims to determine the optimal drug dose tailored for each patient in the future by monitoring drug concentrations in the blood. Participants receive standard treatments with different drugs depending on their cancer type, such as regorafenib, everolimus, sunitinib, cabozantinib, or the combination of encorafenib and cetuximab. Blood samples are collected at baseline, one month, and two months after starting treatment, and additionally if specific adverse events or disease progression occur. These samples help build a pharmacokinetic model to assess drug exposure levels. During the study, patients are monitored according to usual care guidelines, with evaluations including tumor measurements as per local practice. Researchers track trough drug concentrations throughout treatment for up to four years. Patient follow-up includes safety assessments and vital status checks. Participation involves regular blood sampling and clinical monitoring to gather data on drug dosing and patient response over time.

This research aims to evaluate whether adding a digital telemonitoring platform called "CUREETY TECHCARE" to the usual care can improve outcomes for patients with metastatic triple-negative breast cancer who have not received prior treatment and are starting first-line systemic therapy. The study focuses on whether the telemonitoring platform can improve patients' quality of life, reduce hospitalizations, and increase overall survival compared to standard care alone. Participants in the telemonitoring group will use the Cureety platform weekly to complete questionnaires tailored to their treatment. Responses are analyzed by an algorithm that classifies their health status into risk categories, which guide medical staff in monitoring and managing patient care. The medical team uses a dashboard to track patients daily, respond to alerts, and adjust treatments as needed while providing support during standard care consultations. Patients receive messages with advice based on their condition classification. Throughout the study, patients will have their quality of life measured every three months up to 24 months, and researchers will track hospital-free survival and overall survival from the time of randomization up to 24 months. Patients will need to complete web-based questionnaires and have access to internet-connected devices for telemonitoring. The study will monitor safety and treatment effects during this period to understand the benefits of telemonitoring alongside standard care.

Researchers are investigating treatments for advanced metastatic adenocarcinoma of the stomach and gastro-esophageal junction, a serious cancer with low survival rates. Current treatments include chemotherapy combinations and immunotherapy, which have improved outcomes for some patients. However, when cancer progresses after these therapies, options are limited, and new approaches are needed to extend survival and maintain quality of life. This international Phase III trial (FRUQUITAS) tests whether adding fruquintinib, an anti-angiogenic drug, to the oral chemotherapy drug trifluridine/tipiracil can improve survival for patients whose cancer has continued to grow despite prior treatments. The study compares two groups: one receiving trifluridine/tipiracil alone and the other receiving trifluridine/tipiracil combined with fruquintinib. Trifluridine/tipiracil is given orally twice daily on days 1 to 5 and days 8 to 12 of a 28-day cycle, repeated until disease progression or unacceptable side effects. Fruquintinib is taken orally once daily for 21 days of a 28-day cycle, also continued until progression or toxicity. This combination aims to block the tumor's blood supply while providing chemotherapy. The trial evaluates if this approach extends overall survival compared to chemotherapy alone. Participants will be adults with metastatic adenocarcinoma who have received two or three previous treatment lines. They will undergo regular assessments including tumor evaluations per RECIST criteria, blood tests to monitor organ function, and safety checks. Researchers will measure overall survival up to 18 months after starting treatment. The study involves ongoing monitoring for side effects and treatment tolerance, with participation lasting until disease progression, unacceptable toxicity, or withdrawal. Biological samples may also be collected for further research, and informed consent is required before enrollment.