Saint Etienne

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

Malignant hypertension is a very severe type of high blood pressure that can be fatal if not treated. It mainly affects younger adults aged 35 to 55 and carries a high risk of serious heart and kidney problems. Despite its severity and increasing cases, research on malignant hypertension is limited, with diagnostic criteria and treatment guidelines that have not changed since 1929. This study aims to create the first prospective, multicenter registry to better understand the disease's epidemiology, care practices, and biological aspects, and to modernize its definition and diagnosis. The study plans to enroll 500 patients diagnosed with malignant hypertension based on classic criteria, including severe high blood pressure above 180/110 mmHg and evidence of organ damage. It will collect detailed data on patient characteristics, affected organs, and treatment approaches used in various centers. This registry will help develop new diagnostic and treatment recommendations based on solid scientific evidence and may lead to future therapeutic trials. Participants will be followed to evaluate their health outcomes over five years, focusing on their cardiovascular and renal prognosis. Researchers will analyze how patient profiles and the number and type of organ damage affect their long-term outlook. The study will document epidemiology, care pathways, organ involvement, and management strategies in detail to improve understanding and care of malignant hypertension.

Researchers are studying metastatic renal cell carcinoma (RCC), a type of kidney cancer that spreads to other parts of the body, affecting many patients annually in France. This study focuses on patients with oligoprogressive disease, where only a few metastatic sites (1 to 3) show progression while the rest remain controlled under ongoing systemic treatments like targeted therapies or immunotherapy. The goal is to evaluate stereotactic radiotherapy (SRT) as a focused treatment to control these progressing sites and potentially delay the need for changing systemic therapies. The study involves delivering stereotactic radiotherapy, which uses high doses of radiation in one or a few sessions to target metastatic sites specifically. Patients with up to three progressive metastases eligible for SRT will receive this treatment concurrently or sequentially alongside their current systemic therapy. This approach aims to control tumor growth locally and possibly stimulate a broader immune response. The trial is a Phase II study, assessing this treatment strategy in patients receiving first or second-line systemic therapies. Participants will undergo imaging scans to confirm disease progression and lesion sizes, with follow-up assessments to monitor progression-free survival six months after randomization. Researchers will evaluate how well the targeted radiotherapy controls tumor sites and delays further disease progression. Patients will be closely monitored for treatment effects, ability to continue systemic therapy, and overall safety throughout the study period.

Researchers are evaluating new drugs and drug combinations to treat relapsed or refractory peripheral T-cell lymphomas through a platform trial consisting of multiple sub-studies. The study aims to gather early data on these treatments to better identify which patient groups may benefit and to guide future clinical trials. Phase 1 sub-studies focus on determining safe dosage levels, while phase 2 sub-studies aim to find drugs that significantly improve treatment outcomes. Secondary goals include assessing response rates, clinical benefits, progression-free survival, overall survival, and safety profiles of the drugs used. The trial includes several sub-studies with distinct treatments. The Origina-ly-T sub-study is an open-label phase 2 trial studying the safety and effectiveness of roginolisib, given daily until unacceptable side effects, disease progression, or withdrawal. The GolcAza sub-study is an open-label phase 1 trial evaluating the maximum tolerated dose of golcadomide combined with oral 5-azacitidine for follicular helper T-cell lymphoma. Participants receive these drugs daily until the study ends, disease worsens, or withdrawal occurs. During the study, participants will attend scheduled visits for evaluations including scans, laboratory tests, and assessments of treatment response and side effects. Researchers will monitor progression-free survival and determine the maximum tolerated and recommended doses in the sub-studies. The total participation time may last up to two years from enrollment, with ongoing safety and effectiveness monitoring throughout that period.

Researchers are investigating the effects of delaying radiotherapy in patients with low-grade oligodendrogliomas that have 1p/19q codeletion and IDH mutation. These patients often live a long time but risk cognitive decline when treated with immediate radiotherapy plus PCV chemotherapy. The study aims to see if postponing radiotherapy until tumor progression reduces neurocognitive deterioration without affecting overall survival, in a phase 3 randomized trial. Participants will be assigned to one of two treatment groups: one group will receive six cycles of PCV chemotherapy alone, while the other group will receive radiotherapy delivering 50.4 Gy in 28 fractions using IMRT followed by six cycles of PCV chemotherapy. Each cycle of PCV includes oral CCNU on day 1, intravenous vincristine on days 8 and 29, and oral procarbazine from days 8 to 21. Treatments will be carefully administered and monitored throughout the study. During the study, participants will undergo neurocognitive assessments and quality of life evaluations to monitor changes over time. Researchers will measure survival without neurocognitive deterioration over a nine-year period. Laboratory tests, imaging studies, and clinical examinations will be performed as needed to assess safety and disease progression. The study will also track adherence to treatment and follow participants long term to evaluate outcomes and side effects.

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Researchers are evaluating the safety and effectiveness of combining vedolizumab with upadacitinib, called dual targeted therapy (DTT), compared to using vedolizumab alone (monotherapy) in adults with moderately to severely active Crohn's Disease. The main goal is to see if DTT better reduces bowel inflammation and ulcers after 12 weeks of treatment. This Phase 3b trial involves about 396 participants worldwide and also aims to assess the long-term safety and efficacy of these treatments. Participants are randomly assigned in equal numbers to receive either vedolizumab plus upadacitinib or vedolizumab plus placebo during a 12-week induction phase. Those who respond well, showing a significant reduction in disease activity, then continue to a 40-week maintenance phase receiving vedolizumab alone. After this, participants undergo an 18-week safety follow-up period, making the total study participation approximately 70 weeks. During the study, participants will visit the clinic 15 times for assessments including evaluations of disease activity, endoscopic examinations, and safety monitoring. The main outcome measures include the percentage of participants achieving clinical remission and showing improvement in bowel inflammation at Week 12. Researchers will track effectiveness, adverse effects, and overall health throughout the treatment and follow-up periods.

Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib (TAK-279) works in adults with active PsA, considering their prior treatment experiences with specific medications. The study is a Phase 3 trial that compares zasocitinib to a placebo in participants who have or have not been treated with biologic medicines. Participants will receive either zasocitinib tablets or a matching placebo. The study is randomized, double-blind, and placebo-controlled. Treatment will continue with monitoring over a period of up to 60 weeks to assess the effects and safety of zasocitinib. During the study, participants will undergo assessments of joint and skin symptoms, including tender and swollen joint counts and evaluations of psoriatic skin lesions. Researchers will measure how many participants achieve a significant improvement in their arthritis symptoms by Week 16. Safety and response will be monitored throughout the study period, with detailed follow-up visits and evaluations to understand the treatment's impact over time.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.