Levallois Perret

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

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 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.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management in real-world settings.

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are evaluating a combination treatment involving radiotherapy, three chemotherapies (docetaxel, cisplatin, and 5-fluorouracil), and spartalizumab, an anti-PD-1 therapy, for patients with metastatic squamous cell carcinoma of the anus (SCCA). This phase II study aims to improve outcomes for patients who have metastatic or locally advanced recurrent SCCA, as current chemotherapy standards have limitations and resistance to immunotherapy is common. The trial also investigates how these treatments may work together to enhance the immune response against the cancer. The treatment includes administering the modified DCF chemotherapy regimen alongside spartalizumab and radiotherapy. Blood samples are collected at multiple points: before treatment, after delivering 8 Gy of radiotherapy, and at 6 and 12 months after inclusion. These samples help monitor immune responses and tumor DNA changes. The chemotherapy and immunotherapy are given in combination to assess safety and effectiveness in this patient group. Participants will undergo regular scans including CT and PET scans to assess tumor response, and blood tests for immune and molecular analysis. Progression-free survival at one year is the main outcome being measured. The study also carefully monitors side effects and treatment safety. Participants' involvement includes baseline assessments and follow-up visits extending up to at least 12 months to observe treatment effects and collect biomarker data.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating treatments for low and intermediate risk prostate cancer, focusing on erectile dysfunction. This multicenter study compares two radiation therapies: brachytherapy with Iodine 125 and stereotactic body radiotherapy (SBRT). The study aims to analyze the cost and quality of life differences between these treatments over three years, with additional evaluations up to five years including erectile dysfunction, urinary and gastrointestinal side effects, and overall quality of life. Participants are randomly assigned to one of two groups. One group receives brachytherapy delivering a total of 144 Gy to the prostate using Iodine 125. The other group receives SBRT, which delivers 7.25 Gy in five sessions for a total dose of 36.25 Gy, with small markers implanted in the prostate to guide treatment. About 240 patients will be enrolled over two years from approximately twenty centers. During the study, participants will be monitored for erectile dysfunction, treatment side effects, and quality of life for up to five years after treatment. Researchers will perform cost-utility and cost-effectiveness analyses, including measuring quality adjusted life years and erectile dysfunction avoided. Safety and long-term effects will also be assessed to provide comprehensive information for healthcare decision makers.

Researchers are evaluating the benefits of a specialized spa therapy for patients experiencing severe late skin and soft tissue reactions, called fibrosis, which occur at least six months after radiotherapy for breast cancer or upper aerodigestive tract cancer. This research focuses on improving quality of life related to the skin symptoms caused by this fibrosis, a condition that has received limited attention despite its impact. The study is designed as a controlled, randomized, multicenter trial with simple blinding for investigators. The treatment being studied is a dermatologically oriented thermal cure that combines baths with muscle-relaxing and sedative effects, sprays that reduce swelling, and high-pressure thermal water jets applied for several minutes. Participants also attend educational workshops covering relaxation, sophrology, and hygiene. The study compares immediate treatment with delayed treatment after six months to assess the therapy's effects. Participants will undergo self-assessment of their dermatological quality of life six months after treatment using a specific questionnaire (DLQI). Researchers will monitor skin and soft tissue symptoms, collect patient-reported outcomes, and evaluate safety. The total study duration includes treatment and follow-up to capture changes in quality of life and the skin condition over time.

Malodorous wounds, which can be necrotic, infected, malignant, or complicated by fistulas or abscesses, often produce unpleasant odors due to bacteria releasing volatile organic compounds. These odors can cause social and psychological distress such as shame, isolation, and reduced quality of life. Current treatments, including charcoal dressings and antibiotics like metronidazole, have limitations in completely controlling these odors or treating their causes. A new medical device combining odor adsorption with cinnamon's odor-modifying properties is being evaluated for its impact on quality of life and related symptoms. This trial compares a cinnamon-based anti-odor dressing (CINESTEAMae) with a standard charcoal dressing as secondary, non-occlusive dressings applied over the primary wound dressing. The cinnamon dressing includes an absorbent upper layer containing cinnamon powder and a weakly absorbent lower layer. Dressings are changed daily for 14 days. The study involves 98 participants with malodorous wounds across several hospitals in Ile de France. Participants will have data collected about their wounds and treatments on day 0, including quality of life (Wound-Qol), lifestyle, odor-related discomfort, and appetite. Odor discomfort will be assessed by patients daily and also by caregivers and entourage on days 7 and 14. Caregivers will evaluate dressing usability on day 3. Appetite will be measured with the Simple Evaluation of Food Intake scale on days 7 and 14. On day 14, quality of life and any reactions to the dressing will be reassessed. The primary outcome is the reduction in Wound-Qol score by at least 0.4 points, indicating improved quality of life.