Saint Malo

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.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating four different isotonic and hypertonic seawater-based nasal sprays in real-life settings for their effectiveness, safety, usage, tolerance, and user satisfaction. The study focuses on infants, children, adults, and pregnant or breastfeeding women who have acute or chronic sinonasal conditions such as upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis, bronchiolitis, COVID-19, and post-surgery nasal issues. The investigation aims to understand how these devices perform when used as intended across various patient groups. Participants will use one of four CE-marked nasal spray devices according to their specific indications and target populations. The sprays include Respimer Hygiene-Prevention for babies, kids, and adults, Respimer Decongestion for babies from two months old and older, and Phytosun arms Hypertonic nasal wash for children six years and older and adults. Usage instructions vary by product, ranging from 1 to 6 sprays per nostril daily, with different frequencies for treatment and prevention purposes. The study period covers up to three months to assess both short-term and longer-term effects. During the study, participants or their parents will complete online questionnaires and follow healthcare providers advice on nasal wash techniques. Researchers will monitor nasal symptom changes, including intensity and frequency, improvement in nasal breathing, quality of life, and satisfaction with the sprays. Effectiveness will be evaluated from day 0 to day 5 for acute conditions and up to day 14 for chronic issues, extending to three months for seasonal symptom management. Safety, tolerance, and usage patterns will also be recorded throughout the study.

Researchers are studying anaplastic large cell lymphoma associated with breast implants BIA-ALCL, a rare disease that affects only women with breast implants. Due to the low number of cases and the unique nature of this lymphoma subtype, French authorities have recommended creating a registry to collect information on these patients. This registry is open in France and Belgium and is coordinated with a national multidisciplinary meeting for expert review. This study is observational and does not involve any treatment or intervention. It collects data on patients diagnosed with BIA-ALCL to better understand the disease and monitor overall response over a 13-year period. The registry serves as a resource for gathering clinical information and supporting expert consensus discussions. Participants in this registry provide information on their condition, which is reviewed regularly during the multidisciplinary meetings. Researchers track overall response as the primary outcome over 13 years. The study helps to gather long-term data on this rare lymphoma without affecting the usual care patients receive from their own doctors.

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 investigating improved chemotherapy options for patients with metastatic Grade 3 poorly differentiated neuroendocrine carcinomas G3 NEC of the gastro-entero-pancreatic GEP system or unknown origin. These cancers are rare, often diagnosed at an advanced stage, and have limited treatment success with the current standard platinum-etoposide chemotherapy. The study aims to compare the mFOLFIRINOX regimen to the standard platinum-etoposide treatment and to explore molecular characteristics that might predict which patients respond best to each therapy. The trial compares two chemotherapy regimens mFOLFIRINOX, given every 14 days for up to 12 cycles, and platinum-etoposide, administered every 21 days for 6 to 8 cycles or up to 24 weeks. Both treatments are given intravenously on day 1 of each cycle, with continuation depending on disease progression and side effects. The mFOLFIRINOX regimen combines 5-fluorouracil, oxaliplatin, and irinotecan, while the platinum-etoposide regimen includes cisplatin or carboplatin plus etoposide. Molecular profiling of tumors will also be performed to identify biomarkers that may guide therapy choices. Participants will undergo regular scans and laboratory tests to monitor tumor response and side effects. Researchers will measure progression-free survival as the main outcome, along with overall survival, response rates, and treatment tolerability over up to 24 months. The study involves random assignment to one of the two treatment groups and requires ongoing monitoring to assess how well the therapies work and their safety in this patient population.

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 studying patients with pseudoexfoliative glaucoma, a type of glaucoma caused by pseudoexfoliative syndrome, which can make cataract surgery more challenging and prone to complications. This study aims to compare the effectiveness of the Tran cannula, a single-use irrigation device designed to clean pseudoexfoliative material from the eyes drainage system, with increased irrigation using a traditional cannula. The goal is to see which method better lowers eye pressure in patients undergoing cataract surgery who also have glaucoma. Participants will be randomly assigned to one of two groups one treated with the Tran cannula and the other with augmented irrigation using a classical aspiration cannula. Both procedures are done after cataract removal, intraocular implant placement, and viscoelastic aspiration, focusing on cleaning the trabecular meshwork to manage eye pressure. This study uses a double-blind design to fairly compare these two surgical irrigation methods. During the study, researchers will measure intraocular pressure at several key times one day, 30 days, three months, six months, and twelve months after surgery. These measurements will help assess how well each irrigation technique controls eye pressure over time. Participants will be closely monitored throughout the year-long follow-up to evaluate safety and effectiveness of the procedures in managing glaucoma alongside cataract surgery.

Researchers are evaluating the effectiveness and safety of combining EXL01 with nivolumab and FOLFOX as a first treatment for patients with advanced gastric cancer who have a PD-L1 combined positive score CPS of 5 or higher. This phase II multicenter study randomly assigns patients to either the experimental group receiving EXL01 with nivolumab and FOLFOX or a control group receiving just nivolumab and FOLFOX. The study aims to measure how well the cancer responds to these treatments at 4 months using established tumor evaluation criteria. Patients in the experimental group receive nivolumab 240 mg intravenously every two weeks, FOLFOX chemotherapy every two weeks, and take EXL01 orally once daily starting on the first day of each treatment cycle. Those in the control group receive nivolumab and FOLFOX without EXL01. Treatment continues until the cancer progresses, unacceptable side effects occur, or for a maximum of 24 months up to 52 cycles. The study plans to enroll 120 patients, with twice as many assigned to the experimental group. During the study, participants undergo regular CT or MRI scans to assess tumor response, blood tests to monitor health and organ function, and safety evaluations for up to 3 years after starting treatment. Researchers will track outcomes such as overall survival, progression-free survival, duration of response, and safety. Patients will be followed closely with scheduled visits and laboratory tests to monitor treatment effects and side effects throughout the study period.