Colmar

Food Protein Induced Enterocolitis Syndrome FPIES is a type of non-IgE mediated food allergy that usually occurs in infancy and is often not well known by clinicians. The study aims to collect clinical information and allergy test results from children diagnosed with the acute form of FPIES and to observe their condition over three years. It seeks to better understand the evolution of FPIES, including atypical forms, with no prior prospective data available from France. Children diagnosed with acute FPIES will be followed in this national prospective study conducted at sixteen French centers. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used for diagnosis and monitoring. Patients will be seen at an initial visit and then annually for up to three years. If tolerance to the offending food is not acquired, an oral food challenge will be performed in the hospital for confirmation. Participants will undergo yearly allergist visits for evaluation of symptoms and allergy testing. Researchers will measure the rate of tolerance acquisition to foods over one, two, and three years post-inclusion, as well as the progression to IgE sensitization and clinical IgE-mediated allergy. Additional outcomes include the presence of multiple FPIES episodes and related atopic conditions. The study will provide insights into the natural history and management of FPIES in children.

Researchers are studying patients with completely removed non-small cell lung cancer NSCLC who have common mutations in the EGFR gene, specifically Del19 or L858R. The study aims to use broad-panel centralized next-generation sequencing NGS testing at the start to better understand molecular factors that predict outcomes and to investigate mechanisms of resistance to the drug osimertinib after treatment. This research focuses on patients with stage pIB to IIIA NSCLC who have undergone thorough preoperative assessments and quality surgical excision reviews. Participants will have plasma circulating tumor DNA ctDNA tested at various stages before surgery optional, 4 to 8 weeks after surgery, before starting adjuvant chemotherapy or osimertinib if given, every 6 months during follow-up, and at relapse if it occurs. Formalin-fixed paraffin-embedded FFPE tissue blocks from surgery and relapse optional will also be collected for molecular analyses. Treatment with osimertinib as adjuvant therapy is planned for up to 3 years, with chemotherapy given beforehand if needed. During the study, patients will be regularly followed every 3 to 6 months with standard care visits and molecular testing. Researchers will monitor the feasibility of the testing approach over 18 months and track the incidence and severity of any side effects related to osimertinib for about 3 years. This ongoing monitoring aims to better understand relapse mechanisms and improve treatment options in metastatic relapse. The total participation duration aligns with the follow-up and safety monitoring periods outlined.

Researchers are studying patients with 1p19q-codeleted low-grade oligodendrogliomas who have been treated with radiotherapy plus PCV chemotherapy. The study aims to evaluate whether delaying radiotherapy until tumor progression can reduce the risk of neurocognitive decline without affecting overall survival. This is a phase 3 randomized trial sponsored by Hospices Civils de Lyon, focusing on preserving brain function while managing tumor growth. Participants are randomly assigned to one of two treatment groups one group receives six cycles of PCV chemotherapy alone, and the other group receives radiotherapy followed by six cycles of PCV chemotherapy. Radiotherapy delivers 50.4 Gy in 28 sessions using IMRT technique. PCV chemotherapy includes a cycle with CCNU orally on day 1, vincristine intravenously on days 8 and 29, and procarbazine orally from days 8 to 21. Treatment cycles are repeated six times. During the study, participants will undergo neurocognitive examinations and quality of life assessments. Researchers will monitor survival without neurocognitive deterioration over nine years, along with progression-free survival and overall survival. Laboratory tests and physical evaluations will be conducted before and during the study. The trial includes detailed follow-up to assess the long-term effects of the treatments on cognition and tumor control.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating a new approach for adults with moderate to severe ulcerative colitis who need treatment with adalimumab. This Phase IV randomized trial compares standard care with a treat-to-target strategy that includes telemonitoring and patient education. The study aims to assess the impact of using home fecal calprotectin tests and e-monitoring combined with education on disease control by week 48. All participants will initially receive adalimumab with doses starting at 1608040 mg every other week until week 14, then 40 mg every other week until week 26. Dosage may be adjusted up to 80 mg every other week or 40 mg every week based on patient or investigator choice. In addition, patients may receive azathioprine or methotrexate alongside adalimumab until week 38. The study groups differ by follow-up method one group receives standard care with doctor visits every three months, while the other group has e-monitoring, home fecal calprotectin testing, and therapy education. Participants will be involved for about 144 weeks and complete regular assessments including endoscopic exams, clinical evaluations, quality of life surveys, and treatment adherence questionnaires. The study measures success primarily by endoscopic remission at week 48 and also tracks clinical remission, healing rates, patient satisfaction, hospitalizations, colectomies, and safety. Monitoring includes frequent e-monitoring questionnaires and fecal calprotectin testing at home. The trial also evaluates medication compliance and economic outcomes related to treatment.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.

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.

Researchers are investigating the factors that influence whether adolescents seek immediate medical care when experiencing symptoms of testicular torsion. This observational study focuses on adolescents aged 10 to 17 who underwent surgery for testicular torsion between 2020 and 2025. The main goal is to understand what causes delays of six hours or more between symptom onset and first medical visit. Participants are grouped based on their timing of medical consultation those who attended within less than six hours of symptom onset and those who attended six hours or more after onset. The study involves completing a questionnaire designed to assess factors linked to delayed medical care for testicular torsion. During the study, participants will complete the Questionnaire for Assessing Factors Associated with Delay in Seeking Medical Care for Testicular Torsion in Adolescents. Researchers will evaluate barriers to healthcare access, prior knowledge of testicular torsion, perception of symptom severity, and the role of parents or guardians in seeking care. The study aims to identify factors associated with delayed consultation to improve timely medical attention for adolescents with this condition.

Researchers are studying anaplastic large cell lymphoma associated with breast implants BIA-ALCL, a rare disease that affects only women with breast implants. Due to the low number of cases and the unique nature of this lymphoma subtype, French authorities have recommended creating a registry to collect information on these patients. This registry is open in France and Belgium and is coordinated with a national multidisciplinary meeting for expert review. This study is observational and does not involve any treatment or intervention. It collects data on patients diagnosed with BIA-ALCL to better understand the disease and monitor overall response over a 13-year period. The registry serves as a resource for gathering clinical information and supporting expert consensus discussions. Participants in this registry provide information on their condition, which is reviewed regularly during the multidisciplinary meetings. Researchers track overall response as the primary outcome over 13 years. The study helps to gather long-term data on this rare lymphoma without affecting the usual care patients receive from their own doctors.

This research aims to evaluate treatment options for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have experienced disease progression after first-line treatment with pembrolizumab, with or without chemotherapy. The study focuses on patients who need a second line of treatment and investigates the objective response rate to a combination therapy called PCC Paclitaxel, Carboplatin, and Cetuximab. It also monitors disease progression, treatment tolerance, and quality of life over 12 months. Participants receive the PCC protocol, which involves intravenous injections of paclitaxel, carboplatin, and cetuximab administered in cycles lasting one week each for 16 cycles. The carboplatin and paclitaxel are given three weeks out of four, alongside weekly cetuximab. After these cycles, maintenance treatment with cetuximab is given every 14 days until unacceptable side effects, disease progression, or death occurs. During the study, patients will undergo evaluations every 90 days for up to 12 months to measure tumor response and progression. Researchers will assess survival outcomes, treatment safety, and quality of life. Follow-ups may continue according to local practice for up to five years, including monitoring progression-free survival and overall survival. The total participation duration is 12 months, with ongoing safety and quality of life assessments.