Carcassonne

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.

This research aims to find out how common cardiac amyloidosis is among older adults aged 80 years and above who have been hospitalized for heart failure and show thickening of the hearts left ventricle. The study is observational and conducted across multiple geriatric and cardiology centers. It focuses on patients who have experienced heart failure with specific heart muscle changes seen on echocardiography. Participants will be recruited over 24 months and followed for 12 months. At the start, researchers will collect medical history, demographic information, clinical data, frailty status, biological and genetic tests, and echocardiogram results. Bone scans using specific tracers will be performed during or after hospital stays to check for heart muscle involvement. Follow-up will include phone calls every three months to track hospitalizations, care facility admissions, and survival. During the study, participants will have regular assessments including frailty scales, cognitive tests, and questionnaires related to neuropathic pain and independence in daily activities. Researchers will evaluate bone scan results to detect amyloidosis and measure other health and functional outcomes. The study aims to provide a clearer picture of cardiac amyloidosis prevalence and patient condition over one year.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.

This research aims to study people who have had their first episode of symptomatic deep vein thrombosis DVT in their lower limbs to understand the risk and severity of post-thrombotic syndrome PTS, the most common long-term complication of DVT. The study focuses on evaluating how the amount of thrombosis blood clot burden measured by the Venous Volumetric Index VVI on ultrasound relates to the development and severity of PTS assessed by the Villalta scale over 6 months. Participants will be followed at multiple times around 1 week, 1 month, 3 months, and 6 months after diagnosis. At each visit, doctors will assess symptoms and signs to calculate the Villalta score and perform venous ultrasounds to measure thrombosis burden using the VVI. Blood samples will be collected at several visits to study inflammation, coagulation, and clot breakdown factors. Quality of life questionnaires will also be completed at 3 and 6 months. During the study, symptom assessments, ultrasound exams, blood tests, and questionnaires will help researchers understand how the thrombosis burden at baseline and over time relates to the occurrence and severity of PTS. The study ends with the 6-month visit. Researchers will monitor the presence of moderate to severe PTS and changes in clot burden to identify important prognostic factors that may guide future prevention and treatment strategies.

In intensive care units, patients often need central venous catheters for care and safe medication delivery, but these devices can lead to infections. Most prevention focuses on how catheters are inserted and handled, but the length of time the catheter stays in place is a main source of infection. This research compares changing infusion sets every 7 days versus every 4 days to see if less frequent changes increase infection risk while considering impacts on nursing workload and costs. The study involves two groups one where infusion sets connected to the catheter are replaced every 7 days, and another where they are replaced every 4 days, the current standard recommendation. Each replacement involves disconnecting old sets and replacing them with new sterile ones. Both procedures are performed by qualified nurses during the patients ICU stay. Participants are adult ICU patients with a central venous catheter placed less than 72 hours ago and expected to remain for at least 7 days. Researchers will monitor infections related to the catheter from insertion until 48 hours after removal, along with bloodstream infections, catheter colonization, ICU length of stay, mortality, nursing time, and replacement costs. The study follows patients up to 90 days to collect these outcomes and assess the effects of the different replacement schedules.

Researchers are studying a new way to give immunotherapy as maintenance treatment for patients with metastatic non-squamous lung cancer. This phase III clinical trial compares a pulse dosing schedule with a conventional dosing schedule to see if the less frequent pulse dosing is not worse than the standard treatment. The study focuses on pembrolizumab alone or combined with pemetrexed as the maintenance therapy after initial chemotherapy and immunotherapy induction. Participants are randomly assigned to one of two groups. In the Pulse arm, pembrolizumab 200 mg is given every 6 weeks, and pemetrexed 500 mgm is given every 3 weeks if there is no contraindication. In the Control arm, pembrolizumab is given either 200 mg every 3 weeks or 400 mg every 6 weeks, plus pemetrexed 500 mgm every 3 weeks when appropriate. This treatment is given after patients have completed 3 or 4 cycles of induction therapy with pembrolizumab plus platinum and pemetrexed. During the study, participants will be monitored for overall survival over 6 years, along with progression-free survival, response duration, quality of life using several questionnaires, treatment tolerance, and economic factors. Researchers will also perform population pharmacokinetic analyses and study the drugs effect on immune cells. Patients will undergo regular assessments including clinical evaluations and laboratory tests to track treatment effects and safety throughout the study period.

Researchers are investigating personalized treatments for patients with endometrial cancer based on their molecular profiles. This study, part of the RAINBO program, focuses on patients with p53 abnormal endometrial cancer who have completed standard adjuvant chemoradiation therapy. The goal is to see if maintenance treatment with the drug Olaparib can improve recurrence-free survival compared to observation alone. Participants are randomly assigned to either receive Olaparib at a dose of 300 mg twice daily for one year or to be closely observed without additional treatment. All patients have undergone surgery and sequential radiotherapy and chemotherapy, typically following the PORTEC-3 regimen or similar local protocols. The study monitors patients over a three-year period to assess the primary outcome of recurrence-free survival. During the study, participants will have regular assessments including tumor evaluations, organ function tests, and overall health monitoring to ensure safety and treatment adherence. Researchers will also collect data on side effects and disease status throughout the treatment and follow-up periods. The total participation time extends up to three years, including the one-year treatment or observation phase and subsequent monitoring.

This research investigates the treatment options for patients newly diagnosed with metastatic head and neck squamous cell carcinoma. It compares the effects of adding loco-regional radiotherapy and pembrolizumab alone or combined with chemotherapy against systemic treatment alone as the first-line therapy. The study is a phase 3, randomized, open-label trial conducted across multiple centers to evaluate these treatment strategies in this patient population. Participants are randomly assigned to receive either pembrolizumab with or without chemotherapy plus radiotherapy or systemic treatment alone. Pembrolizumab is given as a 200 mg dose every three weeks until disease progression or unacceptable toxicity. Radiotherapy timing varies, starting either before the third pembrolizumab cycle or after, with specific dose schedules targeting involved tumor regions. Chemotherapy, if added, includes carboplatin or cisplatin combined with 5-fluorouracil and is administered for up to six cycles depending on radiotherapy timing and investigator decisions. Throughout the study, participants undergo regular assessments to monitor disease progression and response to treatment. Key measurements include progression-free survival, overall survival, and quality of life questionnaires collected at multiple time points up to five years. Researchers also track treatment side effects, tumor responses, and compliance. The study period extends up to eight years, with primary outcome evaluation after three years and continued follow-up for survival and safety up to five years after randomization.

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.