Creil

Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder PTSD. In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.

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.

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 evaluating first-line immunotherapy-based standard treatments combined with local ablative therapies for patients with oligometastatic non-small cell lung cancer NSCLC. This phase III randomized study aims to compare overall survival and other important outcomes between different treatment approaches for patients with limited metastatic disease. The study is conducted across multiple centers and sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Participants will be randomly assigned to one of two groups. One group will receive radical local treatment RLT targeting all metastatic sites using options such as stereotactic body radiation therapy SBRT, interventional radiology, or minimally invasive surgery, along with standard care SoC-based immunotherapy with or without chemotherapy every three weeks. The control group will receive only the SoC-based immunotherapy with or without chemotherapy. RLT should be completed within three months after randomization and should not delay immunotherapy. Curative treatments for the primary tumor and lymph nodes may be given during the maintenance phase. Throughout the study, participants will undergo regular assessments including imaging to measure progression-free survival and immune-related progression-free survival, quality of life questionnaires specific to lung cancer, and laboratory measures such as circulating tumor DNA clearance. Side effects will be monitored using standard criteria, and an economic evaluation will be conducted. The main outcome is overall survival measured up to two years after the last patient is randomized or death. Participants will be followed with scheduled visits, treatments, and evaluations during the study period.

This research aims to observe patients in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.

Researchers are studying the use of PARP inhibitors, a type of anti-cancer treatment that targets tumor cells, in patients aged 70 years and older with advanced ovarian cancer. This study aims to understand how various clinical, biological, and geriatric factors affect the relative dose intensity RDI of PARP inhibitor therapy in this elderly population. The goal is to gather real-life data to help guide treatment decisions and manage side effects that may impact therapy continuation. The study involves elderly patients starting maintenance therapy with PARP inhibitors for the first time, including Olaparib which may be given with Bevacizumab and Niraparib. These treatments are administered according to approved guidelines. There are no special study visits patients receive routine care, and medical data about disease follow-up is collected at inclusion and every three months for one year. Quality of life surveys OV28 and ELD14 and a geriatric assessment G-CODE are completed every three months, and blood samples are taken at inclusion, six months, and twelve months to analyze genetic factors related to treatment toxicity. Participants are followed for 12 months with regular assessments including medical evaluations, surveys, and blood tests to monitor treatment effects and side effects. Researchers will measure the relative dose intensity of PARP inhibitors at 12 months and evaluate quality of life and geriatric health over time. Genetic testing aims to identify signatures linked to toxicity. This monitoring helps optimize management of therapy-related adverse events and supports treatment adherence in older 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.

Researchers are investigating kidney cancer through the UroCCR network, a national registry and research platform in France that collects detailed real-world data on patient care and disease progression. Established in 2011, this extensive database includes over 21,000 cases from 58 centers and links clinical information with annotated biological samples and national health data. The platform supports multiple types of research, including translational studies, clinical evaluations, and social science investigations, aiming to improve understanding and management of renal cell carcinoma. The study involves adult patients diagnosed with kidney cancer and documents their treatments, including procedures such as radical or partial nephrectomy as determined by the surgeon. Data collected encompasses clinical parameters, imaging, patient-reported outcomes, and socioeconomic factors. The registry supports prospective research projects and ancillary studies, with a focus on real-world practice following national guidelines. It also integrates digital tools for monitoring and prediction, enhancing personalized treatment strategies. Participants contribute data continuously from enrollment through long-term follow-up, which may last until death or withdrawal. The study collects comprehensive clinical, biological, imaging, and patient-reported information, along with biological samples like plasma, urine, and tumor tissue. Researchers measure outcomes related to research project promotion, biological sample collection, epidemiology, treatment monitoring, quality of life, biomarker research, and clinical practice evaluation. This ongoing data collection supports knowledge advancement and improved kidney cancer care over many years.