Bayeux

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.

Chronic pain affects a large portion of adults and elderly people worldwide, leading to significant personal and societal challenges such as reduced work ability and high economic costs. Current treatments often have limited effectiveness and notable side effects. This research aims to better understand chronic pain by creating an e-cohort using a smartphone app and web platform to support personalized follow-up and characterization of patients in pain clinics. Participants will use the eDOL tool, which includes a mobile application for patients and a web platform for healthcare providers. This tool collects various data through repeated questionnaires, weekly assessments, educational modules, and a chat bot. The study involves 20 pain clinics and plans to enroll at least 5000 patients, following them for 24 months to gather comprehensive real-life information on pain, comorbidities, treatment, and psycho-emotional impacts. During the study, participants will regularly provide data through the eDOL app, while researchers will link this information with French health insurance records to analyze healthcare usage and comorbid conditions. The main goal is to characterize chronic pain patients in multiple dimensions over five years. Data analysis will include descriptive and longitudinal methods to understand chronic pain better and improve care approaches.

Researchers are evaluating the effect of digital monitoring of self-reported symptoms on how treatment is managed in patients with advanced clear cell renal cell carcinoma RCC receiving cabozantinib plus nivolumab. This Phase 4 study focuses on the first three months of combined treatment in a real-life setting, aiming to improve patient care by adjusting treatments based on weekly symptom reports. The study is sponsored by Centre Francois Baclesse. Participants receive cabozantinib orally once daily and nivolumab intravenously every two weeks as prescribed in the labeling. During this treatment, a digital monitoring system collects weekly patient reports on treatment tolerance. The system uses an algorithm to classify patients risk levels and generate alerts that may lead to treatment adjustments. This digital telemonitoring platform supports early detection of adverse events related to the combination therapy. Participants will be involved in regular weekly self-reporting of symptoms through a mobile digital device for up to six months. Researchers will assess treatment management adjustments within the first three months and track symptom evolution, fatigue, quality of life, anxiety, depression, pain, and adverse reactions over six months. The study evaluates the feasibility of this digital approach to follow-up and the impact of alerts generated by the monitoring platform on patient management and outcomes.

Researchers are studying how to adjust the dose of fluoropyrimidine chemotherapy based on uracilemia levels in patients with DPD deficiency who have gastrointestinal cancers. This phase II multicenter trial aims to find the best dose reduction strategy to reduce side effects while treating digestive cancers. The main question is which dose reduction is needed for patients with this enzyme deficiency. Participants will receive chemotherapy with doses adjusted according to their uracilemia level. Patients with low uracilemia <16 ngmL will get the full dose, while those with higher levels will receive varying dose reductions or random assignments between 25% and 50% reductions depending on their uracilemia range. Treatments include the FOLFOX or CAPOX chemotherapy regimens, given in cycles every 2 to 3 weeks. During the study, participants will visit the clinic every 2 to 3 weeks for checkups and tests to monitor side effects and treatment response. Researchers will measure the occurrence of serious blood and gastrointestinal toxicities after two treatment cycles and track dose adjustments, toxicity, and survival outcomes over several months and years. The study involves close monitoring of health and treatment effects for up to three years, depending on cancer stage.

Researchers are evaluating the effects of American ginseng combined with vitamin C from Camu Camu berries on fatigue in patients treated for localized breast or gynecological cancer. This multicenter randomized trial aims to assess the safety and efficacy of the dietary supplement Qiseng in improving cancer-related fatigue. The study is randomized, double-blind, and placebo-controlled, led by the Centre Francois Baclesse. Participants receive either Qiseng, containing 200 mg of P. quinquefolius extract 30 mg ginsenosides plus 30 mg vitamin C, or a placebo made of microgranules without active extracts. Both groups take 2 capsules daily for 8 weeks. The trial includes detailed monitoring of fatigue and other quality-of-life aspects during and after treatment. During the study, participants will have their fatigue levels assessed after 1 week and 4 weeks following the 8-week treatment. Researchers will also evaluate other fatigue dimensions, treatment-related side effects, quality of life, anxiety, cognitive function, physical activity, sleep quality, and treatment acceptability at multiple timepoints. The study spans approximately 12 weeks with close follow-up for safety and outcome measurement.

Researchers are evaluating the performance and safety of a mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert in people aged 12 and older who have acute rhinitis with nasal obstruction. The study focuses on how this spray works over a 7-day period to relieve symptoms associated with infections like rhynopharyngitis and rhinosinusitis, as well as non-infectious allergic rhinitis. Participants will use the seawater spray daily during the 7-day study period. The main measure is the sprays effectiveness after 3 days of use. Additional evaluations include effects immediately after the first use and throughout the study on symptoms such as nasal obstruction, secretion thinning, nasal cavity cleansing, irritation relief, and itching. Researchers will also assess patient satisfaction, quality of life improvements, ease of use, and any side effects or device issues. During the study, participants will complete questionnaires to report their symptom changes and feelings about the spray each day. They will be monitored for adverse events and any device problems. The study lasts for a total of 7 days, with assessments at the beginning, during, and at the end of the treatment period to evaluate overall symptom severity and patient experience.

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

This trial investigates whether postmenopausal women aged 60 and older with early-stage, low-risk hormone receptor-positive breast cancer can safely avoid hormone therapy after surgery without increasing the risk of cancer relapse. The study focuses on women with small, low-grade tumors classified as Luminal A subtype, which generally have an excellent prognosis and low recurrence rates. Researchers aim to better understand the balance of treatment benefits and side effects, especially considering the long-term burden of hormone therapy on quality of life. Participants will not receive the standard hormone therapy such as tamoxifen or aromatase inhibitors during the study. All participants will have undergone surgery and possibly radiation therapy prior to enrollment. This study enrolls participants for two years and compares their outcomes to historical data from patients who received hormone therapy, assessing cancer recurrence and health outcomes over time. During the trial, participants will be monitored for up to five years after the last enrollment to track relapse-free survival, incidence of new breast cancer events, distant disease-free survival, overall survival, and quality of life. Evaluations will include questionnaires on quality of life, anxiety, and depression, as well as monitoring for bone health, cardiovascular events, and other treatment-related conditions. The study aims to provide evidence for more personalized treatment approaches and to improve shared decision-making for women with low-risk breast cancer.

Researchers are evaluating the plasma levels of various multikinase inhibitors MKIs in patients with advanced digestive cancers such as 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, multi-cohort interventional study aims to determine the optimal dose of these MKIs for each patient in the future. Participants receive treatment according to standard care for their specific cancer and MKI drug Regorafenib for mCRC, GIST, and HCC Everolimus for gepNET Sunitinib for pNET and GIST Cabozantinib for HCC and the combination of Encorafenib and Cetuximab for mCRC. Blood samples are collected at baseline, one month, and two months after treatment starts, as well as during adverse events or if disease progresses, to measure drug plasma concentrations and build pharmacokinetic models. During the study, participants are monitored through blood draws and tumor evaluations following local clinical practice. Researchers measure trough drug concentrations throughout treatment, along with progression-free survival, overall survival, response rates, disease control, and safety including drug toxicity for up to four years. This long-term follow-up helps understand treatment effects and drug exposure in advanced digestive cancer patients.

The trial investigates 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 their first systemic therapy. It aims to understand if telemonitoring can enhance patient quality of life, reduce hospitalization rates, and improve overall survival compared to standard care alone. Participants in the telemonitoring group will use the Cureety platform weekly to report symptoms. The platform analyzes these symptoms and classifies the patients condition into risk categories, which guide tailored advice and alerts for medical staff. The medical team monitors patients daily via the platform and adjusts care as needed. The comparison group receives standard care without telemonitoring. During the study, patients complete quality of life questionnaires at baseline and regular intervals up to 24 months. Researchers will track time to quality of life deterioration, hospitalization-free survival, and overall survival as primary outcomes. Secondary outcomes include treatment toxicity, treatment failure, clinical deterioration, adverse events, treatment compliance, satisfaction with telemonitoring, and socio-economic impacts. The study involves ongoing monitoring, data collection, and patient questionnaires over two years to assess the benefits and effects of telemonitoring.