Carcassonne

This research aims to find out how common cardiac amyloidosis is in older adults aged 80 years and above who have been hospitalized for heart failure and have thickening of the heart muscle (left ventricular hypertrophy). Patients will be recruited from 31 geriatric or cardiology centers over 24 months. Each participant will have a baseline visit where medical history, clinical data, frailty status, genetic testing, and heart ultrasound data will be collected. Bone scans using 99mTc-DPD or 99mTc-HMDP will be done during or after hospitalization to check for amyloidosis in the heart muscle. After the initial visit, participants will receive follow-up phone calls every 3 months for 12 months to track hospitalizations, nursing home admissions, and death. The main measure is the number of patients diagnosed with cardiac amyloidosis based on bone scintigraphy at the start of the study.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.

Post-thrombotic syndrome (PTS) is a frequent long-term complication of deep vein thrombosis (DVT) that significantly affects patients' quality of life and increases healthcare costs. This research aims to study how the extent of blood clot burden in the veins, measured by a special ultrasound score called the Venous Volumetric Index (VVI), can predict the likelihood and severity of PTS six months after a first episode of symptomatic DVT in the lower limbs. Understanding these predictive factors could help guide better treatment strategies for patients at risk of developing PTS. The study is a multicenter prospective cohort design involving patients diagnosed with a first episode of symptomatic lower limb DVT confirmed by ultrasound. Participants will be followed with clinical assessments and ultrasound scans at one week (only for those in biological research), one month, three months, and six months after diagnosis. Blood samples will be collected at baseline, one week, one month, and three months to examine inflammation and blood clotting factors. Quality of life questionnaires will be completed at three and six months. The VVI score will be calculated from ultrasound data to quantify the clot burden, and the Villalta scale will be used to assess PTS severity over the six-month follow-up period. During each visit, symptoms and clinical signs related to PTS will be evaluated, and color Doppler ultrasound of the lower limbs will be performed. Blood tests will help explore biological markers linked to PTS development. Patients will complete questionnaires about their quality of life to assess the impact of symptoms. The study concludes with the six-month visit, at which point researchers will analyze the association between initial clot burden and PTS outcomes. This comprehensive follow-up aims to improve the prediction and understanding of PTS after DVT.

Patients in intensive care units often require a central venous catheter to deliver medications safely. These catheters, however, can sometimes cause infections, especially the longer they remain in place. Most prevention efforts focus on how the catheter is inserted and handled, but less attention is given to how long the catheter and its connected infusion sets stay in place, which is a key factor in infection risk. This research compares two schedules for changing the infusion sets connected to central venous catheters. One group will have their infusion sets replaced every 7 days, while the other group will follow the usual practice of replacing them every 4 days. During each replacement, all tubing and connectors will be disconnected and swapped with new sterile equipment to reduce contamination risk. Participants will be monitored from catheter insertion until 48 hours after removal, or up to 90 days in the ICU, to track infection rates related to the catheters. Researchers will collect data on infection complications and assess whether the less frequent 7-day replacement increases infection risk compared to the standard 4-day schedule. This study also considers the impacts on nursing workload and medical resource use.

Researchers are evaluating a new way to give immunotherapy for adults with metastatic non-squamous lung cancer. This phase III randomized study compares a longer interval between pembrolizumab infusions as maintenance treatment against the usual schedule. Both groups may receive pembrolizumab alone or combined with pemetrexed, depending on eligibility and absence of contraindications. In the experimental Pulse arm, patients receive pembrolizumab 200 mg every 6 weeks plus pemetrexed 500 mg/m² every 3 weeks if appropriate. In the Control arm, patients get pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks, also with pemetrexed 500 mg/m² every 3 weeks when suitable. This study tests whether the longer dosing interval is not worse than the standard approach for maintenance therapy. Participants undergo regular evaluations including scans and clinical assessments to measure overall survival over 6 years. Eligibility checks include lung cancer diagnosis, prior induction therapy, and health status. Safety monitoring and follow-up continue throughout the study to track treatment effects and patient well-being.

Researchers are evaluating personalized treatment options for patients with endometrial cancer, focusing on those with p53 abnormal (p53abn) molecular profiles. This Phase III trial is part of the RAINBO program, aiming to improve recurrence-free survival by comparing maintenance treatment with the drug Olaparib to observation after standard chemoradiation therapy. The study includes patients who have completed surgery and standard chemotherapy and radiotherapy treatments. Participants are randomly assigned to receive either Olaparib 300 mg twice daily for one year as maintenance therapy or observation without additional treatment. The trial follows patients who have undergone a specific sequence of chemotherapy and radiotherapy, mainly the PORTEC-3 regimen, or similar alternative regimens as decided by their doctors. The study carefully monitors patients during this maintenance or observation phase to assess the effects of Olaparib compared to no treatment. During the study, patients undergo regular assessments including tumor evaluation before starting maintenance therapy, monitoring of organ function, and follow-up visits to track recurrence-free survival over three years. Researchers evaluate safety, treatment adherence, and overall health, ensuring patients meet all study requirements. The total duration of participation includes the maintenance treatment period and long-term monitoring to observe outcomes and side effects.

Researchers are evaluating the effectiveness of combining radiotherapy and pembrolizumab, with or without chemotherapy, compared to systemic treatment alone for patients newly diagnosed with metastatic head and neck squamous cell carcinoma. This phase 3, randomized, open-label trial includes patients with synchronous metastases and aims to assess treatment outcomes over time. Participants receive pembrolizumab 200 mg every 3 weeks until disease progression or unacceptable side effects occur. Loco-regional radiotherapy is given either before or after certain cycles of pembrolizumab, with doses ranging from 54 Gy in 18 fractions to 70 Gy in 33-35 fractions, targeting only involved tumor regions. Chemotherapy with carboplatin or cisplatin combined with 5-FU may be added based on investigator decision and radiotherapy timing, administered for up to 6 cycles. During the study, participants undergo regular assessments to measure progression-free survival, including scans and laboratory tests to evaluate disease status and side effects. Researchers monitor treatment response using RECIST v1.1 criteria and track safety throughout the study, which follows patients for up to 3 years from randomization or until disease progression or death.

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.

Researchers are evaluating the addition of a therapeutic education program combined with nursing phone follow-up compared to conventional management alone in women with non-metastatic breast cancer undergoing adjuvant hormone therapy. The study aims to reduce the impact of side effects from hormone therapy and improve patients' quality of life during the first year of treatment through personalized and coordinated care. Participants who receive the therapeutic education and nursing support program will attend an initial educational assessment around the start of their hormone therapy. They will work with a nurse to set personalized goals and choose relevant workshops as part of an outpatient educational program. This is offered alongside the usual oncology follow-up care. Throughout the first year, patients will be monitored for management of side effects related to hormone therapy. The study collects adverse event information and questionnaire responses via an online platform. The main outcome is to compare how well the education program with nursing phone follow-up manages these side effects versus conventional treatment alone over one year.