Colmar

Food Protein Induced Enterocolitis Syndrome (FPIES) is a non-IgE mediated food allergy that mainly appears in infancy and can cause severe vomiting, diarrhea, and dehydration. This condition is often unfamiliar to many clinicians, and its diagnosis relies on specific clinical criteria established in 2017. This study aims to collect detailed clinical information and allergy test results for children diagnosed with acute FPIES and to describe its progression and atypical forms over three years in a French population. The study will include children aged 0 to 17 years with confirmed acute FPIES, diagnosed either by the 2017 JACI clinical criteria or by oral food challenge. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used to monitor patients. Participants will be seen by allergologists at the start and annually for three years. If tolerance to the offending food is not acquired, an oral food challenge will be conducted in a hospital setting to evaluate resolution. This multicenter French prospective study will gather data on FPIES evolution, including the development of IgE sensitization and clinical symptoms of IgE-mediated allergy. Throughout the study, children will undergo clinical evaluations and allergy testing at inclusion and yearly follow-up visits. Researchers will assess tolerance acquisition over an average of six years, monitor multiple FPIES cases, and record personal atopic conditions. The study will last three years for inclusion and three years of follow-up per patient, aiming to improve management of FPIES in France by understanding its unique food triggers and long-term outcomes.

Researchers are studying patients with completely removed non-small cell lung cancer (NSCLC) who have common EGFR mutations (L858R and Del19). The study aims to include broad-panel centralized genetic testing at the start to better understand factors predicting outcomes and resistance to the drug osimertinib when used after surgery. It also investigates the molecular changes linked to cancer returning during or after osimertinib treatment to find better treatment options if the cancer comes back in a metastatic form. The study involves collecting plasma circulating tumor DNA (ctDNA) samples before surgery (optional), 4 to 8 weeks after surgery, before starting any adjuvant chemotherapy or osimertinib treatment, every six months during follow-up, and at relapse. Tumor tissue samples from surgery and optionally at relapse are also collected for molecular analysis. Patients may receive adjuvant chemotherapy if needed before starting osimertinib, which is given with the intent to treat for three years. Participants will be regularly followed every 3 to 6 months according to standard recommendations. Researchers will monitor genetic markers using blood and tissue samples to study cancer relapse and resistance. The main outcome is to assess the feasibility of this molecular monitoring approach over an 18-month period. Safety and long-term follow-up are included, aiming to improve treatment decisions for patients with resected NSCLC and EGFR mutations.

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 investigating treatments for adults with moderate to severe ulcerative colitis who have not responded well to steroids or other therapies. This Phase IV, randomized, open-label, multicenter trial aims to compare standard care with a treat-to-target approach using telemonitoring and patient education for those starting adalimumab (Humira4). The study will assess if home fecal calprotectin testing combined with e-monitoring and education improves patient outcomes by week 48. All participants will begin treatment with adalimumab at doses of 160 mg, then 80 mg, and 40 mg every other week until week 14, followed by 40 mg every other week until week 26. Based on patient and doctor preference, doses can be adjusted up to 80 mg every other week for two months and continued with azathioprine or methotrexate until week 38. Patients will also receive patient education sessions at weeks 0, 2, 14, 26, and 38, along with regular e-monitoring throughout the study. Participants will be followed for a total of 144 weeks across 20 sites in France. The main outcome is endoscopic remission at week 48, measured by an endoscopic Mayo score of 0. Additional assessments include clinical remission, steroid-free remission, healing rates, quality of life, patient satisfaction, safety, pharmacokinetics, hospitalizations, treatment adherence, and economic impact. Patients will report stool frequency, bleeding, and injection details via e-monitoring at multiple time points. This comprehensive monitoring aims to evaluate treatment effectiveness and patient engagement over time.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease that affects only women who have breast implants. Due to the rarity and unique type of this disease, French authorities have recommended creating a registry to track BIA-ALCL cases. This registry operates in France and Belgium in connection with a national multidisciplinary meeting for case review. This study involves an observational registry that does not include any treatment or intervention. It collects and records data from adult women diagnosed with BIA-ALCL to better understand the disease and its characteristics. Participants in this registry provide information about their diagnosis and disease course. Researchers monitor overall response to the disease over a period of 13 years. The registry helps experts gather important data to support future research and improve understanding of BIA-ALCL in affected women.

Researchers are evaluating a treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have not responded to first-line therapy with pembrolizumab, with or without chemotherapy. This study focuses on patients needing a second-line treatment after failure of pembrolizumab and aims to assess the objective response rate of a combination therapy called PCC (Paclitaxel, Carboplatin, and Cetuximab). The study also monitors disease progression, treatment tolerance, side effects, and quality of life over a 12-month participation period. The treatment involves the PCC protocol, which consists of intravenous injections of paclitaxel, carboplatin, and cetuximab given over 16 weekly cycles. The dosing schedule allows carboplatin and paclitaxel administration three weeks out of four, with weekly cetuximab doses. After completing 16 cycles, patients continue with maintenance cetuximab every 14 days until unacceptable toxicity, disease progression, or death. This approach follows evidence suggesting potential benefits of combining these drugs after anti-PD-1 immunotherapy failure. Participants will undergo regular assessments throughout the study, including evaluations of tumor response every 90 days for up to 12 months. Researchers will collect data on tumor measurements, adverse effects, and quality of life. The study includes laboratory tests and clinical evaluations to monitor patient health, treatment safety, and disease status, ensuring comprehensive follow-up during the entire study period.

Hypopigmented skin changes, particularly Seborrheic Macular Hypopigmentation (SMH), are commonly seen by dermatologists, especially in dark-skinned individuals. SMH presents as scattered, oval-shaped lighter patches mainly on the face and trunk and was previously mistaken for a mild form of vitiligo. However, studies showed no clear link to vitiligo, leading to the recognition of SMH as a distinct condition with unknown causes and no well-established treatments. This research aims to analyze the bacterial and fungal skin microbiome on SMH lesions compared to nearby normal skin and healthy volunteers. The study involves collecting skin swabs from the facial lesions and surrounding areas of patients diagnosed with SMH, and from the same facial regions of healthy volunteers. A sterile cotton swab, premoistened with a special solution, is gently rubbed over the skin for 45 seconds to collect microbiota samples. This process causes slight redness due to pressure. The study includes 10 SMH patients first, followed by volunteers for comparison. Participants will provide informed consent and be physically and psychologically able to take part. Researchers will analyze the skin microbiome differences between SMH lesions, nearby skin, and healthy skin. The primary measure is the bacterial skin microbiome at the start of the study. The study excludes those who recently used antibiotics, antifungal treatments, or had certain skin procedures. The total participation duration and further follow-up details are not specified.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.