Creil

Research shows that women who experience interpersonal violence are at a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination in clinical forensic medicine units, which also offer initial psychological evaluations. However, many women do not attend follow-up appointments. This trial aims to evaluate the effectiveness of a case management algorithm using early phone contact compared to usual care on clinical outcomes after such consultations for female victims of violence. Participants in the intervention group, called VIGITRAUMA, will receive a phone call three weeks after their initial consultation, with the possibility of a second call. If contact is not made after the second call, a postcard will be sent. The control group will receive the standard follow-up care without additional phone contact. The study is a prospective, multicenter, open-label, randomized controlled clinical trial involving women victims of violence. Women enrolled will be evaluated via phone at 3 months, 6 months, and 12 months following their consultation to assess clinical outcomes related to PTSD and violence-related symptoms. The study monitors the effectiveness of early phone contact in improving these outcomes and reducing the risk of PTSD development among participants.

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.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management 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.

Researchers are investigating first-line immunotherapy combined with local ablative treatments for patients with oligometastatic non-small cell lung cancer (NSCLC). This randomized, multicenter, open-label phase III study aims to evaluate the effects of standard immunotherapy-based care alongside radical local treatments on survival outcomes in this specific lung cancer stage. Participants will receive either standard immunotherapy-based treatments, which may include platinum-based chemotherapy combined with anti-PD-1 immunotherapy or anti-PD-1 monotherapy depending on PD-L1 status, or radical local treatments targeting all metastatic sites. These local treatments could involve stereotactic body radiation therapy (SBRT), interventional radiology, or minimally invasive surgery, with plans tailored by a multidisciplinary board. The primary tumor and involved lymph nodes are treated during a maintenance phase using curative-intent approaches such as thoracic radiation or surgery. During the study, patients will be monitored for overall survival from the date of randomization up to two years after the last patient enrolls or until death. Assessments include imaging to confirm measurable lesions, evaluation of organ function, and regular follow-up visits. Patients must agree to contraception requirements and participate in scheduled treatments and examinations throughout the study duration.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.

Researchers are studying the effects of PARP inhibitors, a type of cancer treatment that targets tumor cells, in elderly women aged 70 and older with advanced ovarian cancer. These treatments have shown effectiveness in ovarian cancer but can cause side effects like anemia, thrombocytopenia, and neutropenia, especially in older patients due to changes in drug processing and bone marrow reduction. The study aims to understand how clinical, biological, and geriatric factors influence the ability to maintain the prescribed dose of PARP inhibitors in this population. Participants will undergo regular assessments over a 12-month period while receiving PARP inhibitor therapy for the first time. Every three months, patients will complete two quality of life surveys (OV28 and ELD14) and receive a geriatric assessment by research staff. Blood samples will be collected at the start of treatment and at six and twelve months to perform genetic testing that may identify markers linked to treatment toxicity. Throughout the study, researchers will closely monitor treatment dose intensity and side effects to better manage therapy in older patients. The study includes scheduled clinical evaluations, quality of life questionnaires, and lab tests to track patient health and treatment tolerance. The goal is to gather real-life data to support decision-making about continuing PARP inhibitors in elderly women with ovarian cancer.

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.