Chambery

Researchers are evaluating the safety and effectiveness of the VCFix Spinal System, a medical device designed to treat specific spinal fractures called vertebral compression fractures VCFs in adults aged 21 to 85 years. This study involves up to 8 hospitals in Europe and aims to assess how well the device works and how safe it is for patients with these fractures. The study compares two groups one receiving the VCFix implant with bone cement and the other without cement. Participants will receive the VCFix device implant either with or without the use of PMMA bone cement, according to their assigned study group. The device features in situ adjustment to realign vertebrae, a titanium structure allowing natural bone healing, and the potential to stabilize severe fractures through a pedicle screw component. Treatment will follow intended use guidelines, and researchers will monitor outcomes including pain reduction, function improvement, and device-related complications. During the study, participants will be assessed for changes in back pain and daily functioning at 6 months compared to before treatment. Additional measures include vertebral height restoration, spinal angle improvements, and health-related quality of life at various time points up to 24 months. Safety will be monitored through serious adverse device effects during the first month and adverse events up to two years. The total participation duration extends through follow-up assessments to evaluate both effectiveness and safety.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

Malignant hypertension is a very serious form of high blood pressure that can be fatal if untreated. This research aims to create the first large, multicenter database to better understand this disease, including its modern epidemiology, how patients are currently managed, and the diseases diagnostic criteria. The study will help improve knowledge and may lead to new treatment trials and evidence-based recommendations. The study is an observational registry enrolling patients diagnosed with malignant hypertension based on classic definitions, including severe blood pressure elevation and organ damage. It plans to recruit 500 patients and follow them for five years to study their prognosis and the impact of different patient characteristics and organ involvement. By collecting detailed data on disease features and care pathways, the study hopes to update definitions and management approaches. Participants will be observed over five years, with researchers collecting information on their health status, organ damage, and treatment. The main outcome measured is the five-year prognosis of patients. This long-term follow-up will provide detailed knowledge about the disease course and help identify factors influencing outcomes, without any study treatments or interventions being assigned.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating an experimental drug called odronextamab combined with chemotherapy in adults with Diffuse Large B-cell Lymphoma DLBCL, including those who have not been treated before as well as those with relapsed or refractory disease. The study aims to assess the safety, tolerability, and dosing schedule of odronextamab with chemotherapy, and to compare its effectiveness against the current standard treatment of rituximab combined with chemotherapy. Additional goals include understanding side effects, drug levels in the blood, immune responses to the drug, and impact on quality of life and daily activities. The study consists of three parts Part 1A involves dose escalation to find a safe dose, Part 1B explores two dosing regimens of odronextamab combined with chemotherapy, and Part 2 randomly assigns participants to receive either odronextamab plus chemotherapy Odro-CHOP or rituximab plus chemotherapy R-CHOP. Odronextamab and rituximab are given by intravenous infusion, with chemotherapy drugs including cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone administered as part of the treatment regimen. Participants will be closely monitored throughout the study for side effects, disease progression, and response to treatment. Assessments include measuring dose limiting toxicities, treatment-emergent adverse events, progression free survival, quality of life questionnaires, and blood tests for drug levels and antibodies. The study follows participants for up to 5 years to track long-term outcomes and safety, with regular visits and evaluations scheduled during and after treatment.

Chronic lymphocytic leukemia CLL is the most common type of leukemia affecting blood cells. Researchers are evaluating the safety of combining oral venetoclax with either intravenously infused obinutuzumab or oral acalabrutinib for treating previously untreated CLL. The study focuses on assessing adverse events and changes in disease activity in adult participants. Participants are randomly assigned to one of four treatment groups. Arm A receives oral venetoclax with IV obinutuzumab, including a 5-week venetoclax ramp-up period. Arms B, C, and D receive oral venetoclax combined with oral acalabrutinib, with different venetoclax ramp-up schedules varying between 5 weeks and modified ramp-up periods. The total study duration is approximately 28 months. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect checks, and questionnaires to monitor treatment effects. Researchers will measure the percentage of participants experiencing laboratory tumor lysis syndrome and hyperkalemia during treatment. Safety monitoring and evaluations of tumor burden changes will continue for up to 28 months throughout the study.

Researchers are evaluating an experimental drug called odronextamab combined with lenalidomide in adults who have relapsed or refractory follicular lymphoma FL or marginal zone lymphoma MZL, which are subtypes of Non-Hodgkins lymphoma. The study aims to assess the safety, tolerability, and proper dosing of this new combination and compare its effectiveness to the current standard treatment of rituximab combined with lenalidomide. The research also explores side effects, drug levels in the blood, immune responses to the drug, and impacts on quality of life and daily functioning. The study has two parts Part 1 is a safety phase where all participants receive odronextamab plus lenalidomide to determine the appropriate dose. Part 2 is randomized and compares two groupsone receiving odronextamab with lenalidomide, and the other receiving rituximab with lenalidomide followed by lenalidomide alone. Participants receive these treatments according to the study protocol during these phases. Throughout the study, participants will undergo various assessments including safety monitoring for side effects, measurement of drug concentrations and immune responses, imaging scans to evaluate disease status, and quality-of-life questionnaires. The primary outcomes include tracking dose-limiting toxicities up to 35 days and treatment-emergent adverse events up to 2 years. Longer-term outcomes such as progression-free survival and overall survival will be followed for up to 5 years, with ongoing evaluations to understand the treatments impact over time.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.