Evreux

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

This research aims to assess the safety and performance of Teknimed arthroplasty products, including the CEMFIX and GENTAFIX bone cement families and the CEMSTOP cement restrictor, which have been used for more than 20 years in joint replacement surgeries. The study focuses on real-life long-term data to confirm previous findings on these products safety and effectiveness in patients undergoing joint replacement due to osteoarthritis, osteonecrosis, trauma, or revision surgeries. The study is a global, multicenter, observational trial that collects both retrospective and prospective data from patients receiving primary or revision joint replacements involving Teknimed bone cements and cement restrictors. Different groups include patients undergoing knee, hip, or shoulder surgeries with various cement types. Patients receive treatment as part of their standard medical care, without additional interventions mandated by the study. Participants will be monitored according to local medical practices, with data collected on outcomes such as implant survival, infection rates, pain levels, patient satisfaction, function restoration, complications, and adverse events. The primary outcomes cover up to 15 years, focusing on device lifetime and postoperative infections, while secondary outcomes evaluate patient-reported and clinical measures over five years. This long-term follow-up aims to provide comprehensive safety and performance information for these arthroplasty products.

This research evaluates how virtual reality combined with hypnosis affects anxiety in patients undergoing scheduled orthopedic surgery with regional anesthesia. It compares anxiety levels and patient satisfaction between those using virtual reality and those receiving standard care. The study is randomized and seeks to understand if virtual reality can influence sedation needs during surgery. Participants are randomly assigned to one of two groups. One group experiences a virtual reality session with hypnotic content through a headset, starting before regional anesthesia and possibly continuing throughout surgery. The other group receives standard anesthetic and surgical care without virtual reality. The study is conducted during the intraoperative period. During the study, researchers monitor sedation use from arrival in the operating room until surgery ends. They also collect baseline data such as patients age, sex, type of surgery, and ASA score. Anxiety and satisfaction questionnaires are used to compare groups. The total participation timeline covers the surgical procedure and associated assessments.

Researchers are conducting an observational study called the France PCI Registry to monitor and improve care in interventional cardiology, focusing on procedures like coronary angiography and angioplasty. This national observatory started in 2014 in the Centre Val de Loire region and aims to build a reliable database of interventional cardiology activities. The study is led by the Club Rgional des Angioplasticiens de la rgion Centre and seeks to optimize patient care times, especially for those with STEMI a type of heart attack. The study collects data fully integrated with usual coronary activity reporting software across multiple catheterization labs. It tracks interventional cardiology activities over a year and monitors secondary outcomes such as improving care times for STEMI patients within 24 hours. There are no investigational drugs or treatments administered, as this is an observational study gathering information from routine clinical practice. Participants who have undergone coronary angiograms or angioplasty are involved through data collection during their usual care. The study regularly evaluates data quality to maintain an exhaustive and reliable database. Researchers measure the volume and quality of interventional cardiology procedures and how quickly STEMI patients receive care. Participation lasts as long as the data collection period, with ongoing observation but no additional interventions or treatments.

Researchers are evaluating the feasibility and impact of remote care for patients diagnosed with low-risk thromboembolic disease. The study aims to understand how well healthcare professionals, including hospital physicians and primary care doctors, can organize care remotely, and to assess rates of complications, hospitalizations, and treatment compliance over 6 months and 1 year. Participants will follow treatment guidelines based on national recommendations. Participants will receive a 4G tablet for the entire study period to complete questionnaires, access educational information about their medications, participate in remote consultations, and track their treatment adherence. The study focuses on measuring satisfaction with the organization of care by patients and healthcare providers, along with monitoring clinical outcomes related to thromboembolic disease. During the study, participants will be regularly assessed through questionnaires and remote consultations using the tablet. Researchers will evaluate satisfaction levels using three different scales for patients, hospital physicians, and primary care physicians at 6 months and 1 year. They will also monitor complication rates, hospitalizations related to thromboembolic disease, and treatment compliance at these time points. The total duration of participation spans at least one year with ongoing monitoring and data collection.

Researchers are studying patients who have lived for three years or more after being diagnosed with metastatic lung cancer and who are no longer receiving cytotoxic chemotherapy. The study aims to understand these patients clinical characteristics, health status, socioeconomic impacts, quality of life, and their ability to return to work. This observational research focuses on both non-small cell lung cancer NSCLC and small cell lung cancer SCLC. Participants will be observed over time without receiving experimental treatments. They will complete several questionnaires related to quality of life, anxiety, and depression at the start of the study, then at 6 and 12 months, and annually for up to five years. Their health and treatment history, including any ongoing therapies like immunotherapy or targeted therapy, will be recorded throughout the study. During the study, participants will continue their usual medical care and attend regular consultations as needed. Researchers will collect data through questionnaires and health evaluations to measure clinical characteristics, health status, socioeconomic factors, and psychological well-being. The main outcomes include baseline clinical data and repeated assessments over five years to better understand long-term survivorship after metastatic lung cancer diagnosis.

This research aims to study the health and development of children who are taken into care by child protective services CPS and to evaluate the PEGASE program designed to provide regular, standardized medical follow-ups, including mental and physical health assessments. The study focuses on children under CPS care who are not enrolled in the PEGASE program, creating a control group called the ESPER cohort. The goal is to compare health outcomes and program effectiveness over time, with a special focus on mental health after two years. Children in the ESPER cohort are followed using the usual care practices of their CPS centers without the additional PEGASE standardized assessments. The study collects data at the time of placement and then at one and two years later through questionnaires and health records, including developmental assessments using standardized tools like ASQ-SE and ASQ-3. The program includes children less than 42 months old at their first entry into the center and involves a follow-up period of two years. Participating children will have health and developmental data collected at baseline, one year, and two years, either in person or by phone if no longer in care. Information includes mental health, physical growth, communication and motor skills, school integration, and care pathways. The primary outcome is mental health after two years, with secondary outcomes covering various developmental and health measures and a cost-effectiveness evaluation. The study plans to enroll 220 children over 24 months, with each child followed for 24 months.

Lower limb trauma that requires immobilization is common and raises the risk of venous thromboembolism VTE. The TRiPcast score helps identify patients at high risk score 7 who need preventive anticoagulant treatment. While low molecular weight heparins LMWH are standard, recent studies suggest they may not fully prevent VTE in high-risk patients. This trial compares rivaroxaban, a direct oral anticoagulant, with LMWH to assess which is more effective and easier to use for preventing blood clots in these patients. Participants with lower limb trauma and a TRiPcast score of 7 or higher are randomly assigned to receive either rivaroxaban 10 mg orally once daily or LMWH injections during the period of immobilization, until they can bear weight on the limb again. Treatment begins in the emergency department and continues at home, with dosing for LMWH following local guidelines and rivaroxaban fixed at 10 mg daily. Throughout the study, participants are monitored at 45 and 90 days after treatment start to track symptomatic blood clots and bleeding events. Their satisfaction with the treatment is also assessed. Researchers measure the rate of symptomatic venous thromboembolic events primarily at 45 days and evaluate safety, treatment satisfaction, and cost-effectiveness at 90 days. The total follow-up lasts up to 90 days to fully capture outcomes and treatment impact.

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.

This research aims to assess the prevalence and changes over time of medico-psychological characteristics in children and adolescents placed full-time in child protective services structures in specific regions. The study focuses on how these characteristics evolve during the first two years following placement, considering different age groups. It investigates various behavioral and developmental conditions including psychiatric disorders as classified by DSM 5. Participants will undergo a series of assessments including a first interview with a psychologist shortly after placement, where cognitive tests, psychiatric classifications, and psychological evaluations are conducted. Follow-up assessments occur at one year M12 and two years M24 after inclusion, focusing on psychiatric and psychological status. The study uses questionnaires, scales, and cognitive tests as behavioral interventions. Throughout the study, researchers will collect detailed information on psychiatric disorders, cognitive abilities, attachment disorders, emotional and behavioral regulation, hallucinations, mentalization capacity, eating disorders, substance use, adverse life events, care pathways, coping strategies, depressive symptoms, and global functioning at the start and follow-ups. Participation involves structured evaluations at three time points over two years, helping understand developmental trajectories and adaptive methods in this vulnerable population.