Calais

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.

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating the drug levels, effectiveness, and safety of Deucravacitinib in children aged 4 to under 18 years who have moderate to severe plaque psoriasis. The study includes two age groups: Cohort 1 for ages 12 to under 18, and Cohort 2 for ages 4 to under 12. Each cohort has two parts, with Part A focusing on determining the appropriate dose levels of Deucravacitinib, and Part B assessing how well two selected dose levels work and their safety. A long-term extension phase lasting up to five years will monitor the ongoing safety and tolerability of the medication in young participants who completed the initial study parts. Participants receive Deucravacitinib or a matching placebo at specified doses on set days. Part A evaluates drug levels to select doses for Part B, which then measures efficacy and safety of the chosen doses in pediatric patients with moderate to severe plaque psoriasis. Following Parts A or B, participants may enter the long-term extension period to continue safety and tolerability assessments over several years. Throughout the study, researchers will measure drug concentrations in the blood at Week 2 and assess clinical improvements at Week 16 using the Psoriasis Area and Severity Index and Physician's Global Assessment scores. Safety monitoring includes tracking adverse events, serious adverse events, and growth measures such as weight, height, and sexual maturation stages for up to 316 weeks. This comprehensive evaluation helps understand how the drug works and its impact on children's health over both short and long periods.

Researchers are evaluating the safety and effects of Abrocitinib, a medication given as a tablet once daily, for adults with moderate to severe atopic dermatitis (AD), a long-lasting skin condition causing inflammation, redness, and irritation. This observational cohort study aims to understand how Abrocitinib works in real-life clinical settings and its impact on patients with moderate-to-severe chronic AD who are eligible to receive this treatment. All participants will receive Abrocitinib daily and may continue using medicated topical treatments for their AD at the same time. The study lasts for 24 months, during which participants will visit the study clinic approximately five times, or about once every four to six months. These visits will allow researchers to monitor the effects and safety of the treatment in a real-world context. Participants will be closely observed for changes in their AD severity, specifically looking for improvements measured by the Investigator's Global Assessment (IGA) score at 16 weeks. The study will also assess safety and how patients manage their treatment over time. Overall, the study aims to provide valuable information on how Abrocitinib affects adults with moderate-to-severe atopic dermatitis in everyday clinical practice.

Chronic use of nitrous oxide can cause toxicity leading to neurological problems such as combined sclerosis of the spinal cord. This can result in difficulties walking or sensations like numbness and tingling, which may improve or worsen to the point of requiring a wheelchair. Recently, cases of blood clots have also been linked to nitrous oxide use. Blood or urine tests for nitrous oxide are not commonly done because the gas leaves the body quickly, so other markers like vitamin B12 and homocysteine levels are studied instead, though no official monitoring guidelines currently exist. The exact biological processes causing these health problems are still not well understood. The study involves collecting blood samples from participants for biological analysis to better understand markers related to nitrous oxide use. Participants include current or former recreational nitrous oxide users, both with and without clinical signs or biological effects from use. Blood samples are preserved for testing as part of routine care within the study framework. Participants will be monitored with blood tests to measure markers linked to nitrous oxide consumption over about one year. The main outcome measured is the change in blood markers related to nitrous oxide use during this period. The study requires participants to consent and be socially insured, and it excludes pregnant or breastfeeding women and those who have not used nitrous oxide recently or are unwilling to complete the study.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are evaluating the effects of Qiseng®, a dietary supplement made from American ginseng extract combined with vitamin C from Camu Camu berries, on fatigue in female patients treated for localized breast or gynecological cancer. This multicenter randomized, placebo-controlled, double-blind trial aims to assess the safety and effectiveness of Qiseng® in reducing cancer-related fatigue experienced after treatment. Participants will be randomly assigned to receive either Qiseng® or a placebo, each given as two capsules daily for 8 weeks. The study involves a comparison between these two groups to monitor changes in fatigue levels over the treatment period. During the trial, researchers will assess participants' fatigue scores using a visual scale at one week and four weeks after finishing the 8-week treatment. Participants will be monitored for safety and adherence throughout the study, which includes follow-up assessments to measure the change in fatigue associated with the intervention.

Researchers are conducting a global, multicenter, randomized, open-label Phase 2/3 trial to study the effects of Datopotamab Deruxtecan (Dato-DXd) combined with carboplatin or cisplatin versus gemcitabine combined with carboplatin or cisplatin. This study focuses on participants with locally advanced or metastatic urothelial carcinoma (la/mUC) who have experienced disease progression during or after treatment with enfortumab vedotin (EV) plus pembrolizumab. The research aims to assess preliminary efficacy, safety, and tolerability, and to identify the recommended Phase 3 dose (RP3D) based on Phase 2 results before proceeding to the Phase 3 portion. Dato-DXd will be given as an intravenous infusion every three weeks at a dose of 4 mg/kg or 6 mg/kg during Phase 2 or the RP3D during Phase 3. Carboplatin and cisplatin will also be administered intravenously every three weeks, with carboplatin dosed at AUC 4.5 or 5.0 mg·min/mL and cisplatin at 70 mg/m2. Gemcitabine will be given intravenously at 1000 mg/m2 on Days 1 and 8 of each three-week cycle. Participants eligible for cisplatin will receive it; those ineligible will receive carboplatin. The study starts with Phase 2 (Part A) to assess early outcomes and safety, then moves to Phase 3 (Part B) depending on those findings. Participants will be monitored for overall response rate, progression-free survival, and overall survival over periods up to 34 months in Phase 2 and 38 months in Phase 3. Assessments include radiographic evaluations to document disease progression or death. Safety and treatment tolerability will be closely observed throughout. Participants will provide tumor tissue samples for biomarker testing, and dosing will be tailored based on eligibility and investigator judgment. This comprehensive monitoring aims to evaluate the treatments' impact and patient outcomes over the study duration.