Cahors

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.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

Researchers are studying rheumatoid arthritis RA, focusing on patients who have not responded well to initial treatments like methotrexate or leflunomide. The trial compares two treatment strategies for patients positive for specific auto-antibodies ACPA who initially receive TNF inhibitors. The goal is to see if starting with TNF inhibitors followed by abatacept, a cell-targeted biologic drug, improves remission rates compared to continuing TNF inhibitors alone. This phase 3 randomized controlled trial aims to optimize treatment and tolerance in RA patients. All participants begin with 12 weeks of subcutaneous TNF inhibitor treatment. After this, those showing a moderate response are randomly assigned to one of two groups one switches to abatacept for 36 weeks, while the other continues TNF inhibitors for the same period. If patients in the TNF inhibitor group do not respond sufficiently at 24 or 36 weeks, a second TNF inhibitor may be offered. Concomitant use of methotrexate or leflunomide and low-dose steroids is permitted under stable conditions. Participants will attend regular visits for clinical evaluations using various disease activity scores and tolerance assessments throughout the 48-week study period. Researchers will measure remission rates, changes in auto-antibody levels, flare frequency, steroid use, serious adverse events, and quality of life indices. The primary outcome is the percentage of patients achieving remission 36 weeks after randomization, with additional secondary outcomes assessed at multiple time points.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are investigating the best way to manage treatment withdrawal of denosumab Dmab in women with postmenopausal osteoporosis. Denosumab is an effective treatment, but stopping it can cause a rebound effect, including increased bone turnover markers, loss of bone density, and a higher risk of vertebral fractures. This study aims to compare two strategies using zoledronate ZOL infusions to reduce these rebound effects after Dmab withdrawal. Participants receive an initial ZOL infusion six months after stopping denosumab. One group receives a second ZOL infusion guided by biomarker levels crosslaps if these reach a certain threshold within one year. The other group follows a standard treatment with a potential rescue second infusion at month 12 if there is an unfavorable outcome or high risk of fractures. This open-label randomized trial tests whether biomarker-driven additional treatment offers better protection against bone loss. During the study, participants will have bone mineral density BMD measured in the lumbar spine and hip at baseline, one year, and two years. Bone turnover markers and fractures will also be monitored regularly up to two years. The main outcome is maintaining lumbar BMD after one year of zoledronate treatment. Safety and treatment response will be assessed throughout the study duration, which includes follow-up visits at months 3, 6, 9, and 12.

Researchers are evaluating treatments for patients with previously untreated follicular lymphoma who have a FLIPI score of 2 to 5. This phase III, randomized, open-label trial compares the combination of mosunetuzumab and lenalidomide with anti-CD20 monoclonal antibody plus chemotherapy. The study aims to assess the efficacy and safety of these treatments in managing this type of lymphoma. Participants enter a screening period lasting up to 6 weeks before randomization and treatment. Those randomized to the experimental arm receive mosunetuzumab with step-up dosing followed by lenalidomide over an induction phase of about 11 months, then a maintenance phase lasting up to 17 months, totaling around 30 months of treatment. The control arm includes different combinations of anti-CD20 antibodies with chemotherapy drugs CHOP or bendamustine over induction phases of about 5 months, followed by maintenance for up to 22 months, also totaling about 30 months. Patients are not allowed to switch from control to experimental treatments. Throughout the study, participants undergo regular follow-up visits for up to 7 years after the last patient is randomized. Follow-up includes assessments every 3 months for the first two years, then every 6 months for three years, and yearly thereafter. Researchers monitor progression-free survival, overall survival, response rates, adverse events, and other health measures. The total study duration is expected to be around 10 years from the start of enrollment to final follow-up.

Researchers are studying advanced cancer of the stomach and the gastro-esophageal junction, a serious disease with low survival rates. The trial focuses on patients whose cancer has progressed after two or three prior treatments. The study aims to evaluate whether combining the oral drug trifluridinetipiracil with the anti-angiogenic drug fruquintinib can improve survival compared to trifluridinetipiracil alone. This international Phase III trial builds on recent advances in immunotherapy and targeted therapies for this cancer type. Participants are randomly assigned to one of two groups. One group receives trifluridinetipiracil alone in 28-day cycles, taking the drug by mouth twice daily on Days 1 to 5 and Days 8 to 12 with rest days in between, repeated every 4 weeks. The other group receives the same trifluridinetipiracil schedule plus fruquintinib by mouth once daily for 21 days each cycle. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants undergo regular assessments to monitor overall survival up to 18 months after starting treatment. Researchers will also measure progression-free survival during this period. Patients will have tumor evaluations, laboratory tests, and monitoring for treatment side effects. Participants must meet specific health criteria and agree to biological studies. The study provides close follow-up to evaluate the effects of the treatments over time.