Evreux

Researchers are studying the biological features of advanced ALK-rearranged non-small cell lung cancer (NSCLC) in patients treated with new generation tyrosine kinase inhibitors (TKIs) as their first therapy. This study is part of the national EXPLORE ALK cohort, a multi-center observational project in France, focusing on patients with this specific genetic alteration. The goal is to better understand the tumor biology and resistance mechanisms by analyzing samples from diagnosis through disease progression. The study collects tumor tissue samples at diagnosis and, when possible, at disease progression for RNA sequencing to identify ALK fusion partners, variants, and co-mutations. Blood samples are also taken at diagnosis, first tumor evaluation, and at progression to analyze circulating tumor DNA (ctDNA) using next-generation sequencing panels that detect mutations, fusions, and other genetic changes. These biological analyses are centralized at specialized centers such as the Léon Bérard Center and Rouen University Hospital. Patients are treated with approved ALK inhibitors like alectinib, brigatinib, lorlatinib, or entrectinib as part of their standard care. Participants will provide blood samples at multiple time points and, if possible, tumor biopsy samples for detailed genetic analysis. Researchers will monitor the progression-free survival from treatment start for up to 72 months. The study involves regular evaluations to assess tumor status and collect biological material to track genetic changes over time. Consent for sample collection and participation in the study is required, and patient data is managed within the national health system framework.

Researchers are evaluating the safety and performance of Teknimed's arthroplasty products, including CEMFIX e and GENTAFIX e bone cements and the CEMSTOP e cement restrictor, which have been used for over 20 years. These products are designed to help fix joint prostheses to bones during joint replacement surgeries, which commonly address conditions like osteoarthritis, osteonecrosis, and trauma. The study focuses on collecting real-life long-term safety and effectiveness data through a retrospective and prospective observational design. The study involves patients undergoing cemented joint arthroplasty procedures using Teknimed's bone cements and cement restrictor. It is a global, multicenter, single-arm, non-controlled study where participants will be followed according to local medical care standards. Both patients who have already had surgery with these products since January 2016 and those scheduled for such procedures are included. Participants will be monitored for up to 15 years, with primary outcomes including survival rate of the device and rates of superficial or deep postoperative infections. Data collection includes clinical follow-up visits and routine medical care assessments. The study aims to confirm the long-term safety and performance of Teknimed arthroplasty products in real-world use.

Researchers are evaluating how virtual reality combined with hypnosis affects anxiety and sedation use in patients undergoing scheduled orthopedic surgery with regional anesthesia. This study compares two groups: one receiving virtual reality sessions during surgery and a control group receiving standard care without virtual reality. Anxiety and satisfaction are assessed through questionnaires to understand the impact of the intervention. Patients in the virtual reality group use a headset that provides immersive visual and auditory calming environments chosen by the patient. The session starts before regional anesthesia is given and may continue throughout the entire surgery. The control group receives usual anesthetic and surgical care without virtual reality. During the study, participants complete anxiety and satisfaction questionnaires to compare experiences between the groups. The primary outcome measured is the rate of sedation use during the intraoperative period, from arrival in the operating room until the end of surgery. The study includes adults aged 18 years or older undergoing planned orthopedic procedures with regional anesthesia.

Rigorous assessment of clinical practice plays an important role in improving patient care and outcomes in interventional cardiology. This multicenter observational study called CRAC began in 2014 in the Centre Val de Loire region of France. It uses usual coronary activity report software to collect high-quality, reliable data from five interventional cardiology catheterization labs in the region. This approach aims to create an extensive and trustworthy database that could be expanded to other regions in France. The study collects data continuously from patients who have undergone coronary angiograms or angioplasty procedures. There are no specific interventions or treatments assigned as this is an observational registry monitoring routine clinical activity in interventional cardiology. The data collection and quality assessment are integrated into the regular reporting systems used by participating centers. Participants provide their data while receiving standard care. Researchers regularly evaluate the quality of the collected data to ensure accuracy and completeness. The main outcome being measured is the census of interventional cardiology activity over one year. The study focuses on building a comprehensive national registry to support improved care through careful monitoring and analysis of interventional cardiology procedures.

Researchers are evaluating how remote care can be used for patients diagnosed with low-risk thromboembolic disease, which includes deep vein thrombosis or pulmonary embolism with a low risk of mortality. This study focuses on the feasibility of coordinating care between hospital physicians and primary care doctors, as well as assessing complication rates, hospitalizations related to the disease, and treatment compliance at 6 months and 1 year. The study aims to understand the impact and organization of remote care in this patient group. Participants will receive treatment based on national recommendations and will be provided with a 4G tablet for the entire study period. This tablet will be used to complete questionnaires, access educational information about their medications, have remote consultations, and monitor treatment compliance. This setup supports communication and patient education remotely throughout the study duration. During the study, researchers will assess satisfaction with the care organization using scales completed by patients, hospital physicians, and primary care physicians at 6 months. They will also monitor complications, hospitalizations, and treatment adherence over 6 months and 1 year. The study includes ongoing monitoring through the tablet and remote consultations to gather data on these outcomes and ensure patient safety.

Researchers are studying patients who have metastatic lung cancer and have survived for more than three years after their diagnosis without receiving cytotoxic chemotherapy. The focus is on understanding their clinical features, health status, quality of life, and socio-economic impacts, including the effects of cancer treatments, the occurrence of new diseases, and return to work. This observational study aims to better identify the needs of these long-term survivors to improve their management. Participants will complete several questionnaires, including the Hospital Anxiety and Depression Scale (HAD), the Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13), and the Aix-Marseille-University (AMU) questionnaire. These are designed to assess anxiety, depression, lung cancer symptoms, treatment side effects, and overall quality of life. Questionnaires are completed at the start of the study, at 6 and 12 months, and then yearly for up to 5 years. Participants will be followed during their regular medical consultations as per usual care at participating centers. Throughout the study, researchers will collect information on clinical characteristics, treatment details, health status, socio-demographic factors, and quality of life measures. Data will be gathered at baseline and during follow-up visits up to 5 years. This information will help assess the long-term impact of lung cancer and its treatments on patients who are living well beyond initial expectations.

Many children experience abuse or neglect each year, which can lead to both short-term and long-term effects on their mental and physical health. In France, over 300,000 minors are under child protective services (CPS), but there is limited data on their health status and how it changes over time. The PEGASE program was created to provide standardized medical follow-up, both physical and psychiatric, for children taken into care by CPS. This program aims to detect and address health issues early by offering regular assessments and care. Children enrolled in the PEGASE program receive an initial comprehensive health check when they enter care, followed by 20 scheduled evaluations up to age 7. These assessments use standardized tools to identify potential developmental delays or disorders early, allowing timely intervention. The study includes a control group of children under CPS care who do not participate in PEGASE, called the ESPER cohort, to compare the program's effectiveness and provide valuable health data for this vulnerable population. Participants in the ESPER cohort will be followed for two years with data collected at enrollment, one year, and two years. Information such as health, development, school integration, and care pathways will be gathered through questionnaires and health records, either in person or by phone. Researchers will evaluate mental health changes over two years as the primary outcome and will also assess physical health, development skills, and the program's cost-effectiveness. The study plans to include 220 children under 3.5 years old who are newly entering CPS care and whose guardians agree to participate.

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score \<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

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.

Researchers are studying children and adolescents placed full-time in Child Protective Services in the regions of Seine-Maritime and Eure, as well as in nurseries in Le Havre or Rouen. The study aims to assess the prevalence and changes over time of medical and psychological characteristics, focusing on behavior, development, and mental health issues in these young individuals, grouped by age. The goal is to understand vulnerability and resilience factors that influence their developmental paths and adaptive methods during their time in the child welfare system. Participants undergo several assessments starting shortly after their arrival in the care structure. At the beginning (M0), a psychologist conducts an interview that includes cognitive testing, psychiatric classification, and psychological evaluations. Follow-up assessments occur at 12 months (M12) and 24 months (M24) after placement, focusing on psychiatric classification and psychological evaluations to monitor changes in mental health status over time. Throughout the study, researchers collect data on psychiatric disorders using criteria from the DSM 5 at inclusion, 1 year, and 2 years after placement. This includes detailed psychological assessments and cognitive tests administered by a psychologist. The study tracks the presence and nature of psychiatric disorders and other psychological factors to understand how these evolve during the child or adolescent's time in protective care. The total participation lasts for two years with ongoing monitoring at set intervals.