Quint Fonsegrives

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating the disease-free survival in participants with high-risk non-muscle-invasive bladder cancer HR-NMIBC who have previously received Bacillus Calmette-Gurin BCG treatment. This Phase 3 trial compares a new treatment called TAR-210 with the investigators choice of intravesical chemotherapy. The study focuses on participants with specific fibroblast growth factor receptor FGFR alterations and aims to find out which treatment better prevents cancer recurrence or progression after BCG therapy. Participants are randomly assigned to one of two groups. Group A will have TAR-210 inserted into the bladder starting on Day 1 and continuing for about 2 years. Group B will receive either mitomycin C or gemcitabine chemotherapy, chosen by the investigator, given once weekly for 4 to 6 weeks induction, followed by monthly maintenance doses for up to 1 year, with a possible second year of maintenance at the investigators discretion. All treatments are delivered directly into the bladder intravesically. During the study, participants will be monitored for up to 5 years to track disease-free survival and other outcomes such as recurrence-free survival, time to next intervention, disease worsening, progression, and overall survival. Researchers will also assess side effects, laboratory and vital sign changes, and quality of life using specific questionnaires. The study includes regular evaluations and safety monitoring throughout the participation period, which may last several years.

Researchers are evaluating the effectiveness of TAR-210 compared to investigators choice of intravesical chemotherapy in people with intermediate-risk non-muscle invasive bladder cancer IR-NMIBC who have specific FGFR mutations or fusions. This Phase 3 randomized study aims to compare disease-free survival between these treatment options, with the goal of understanding which may better prevent recurrence or progression of the cancer. Participants are randomly assigned to one of two groups. Group A receives TAR-210, which is inserted into the bladder on Day 1 and removed after 12 weeks, with one insertion every 12 weeks over about one year. Group B receives intravesical chemotherapy using mitomycin C or gemcitabine, chosen by the investigator, given once weekly for 4 to 6 doses followed by maintenance treatment for at least six months up to one year. The study includes a substudy with similar treatment groups. During the trial, participants will undergo multiple cystoscopies and urinary tumor resections as needed to monitor for disease recurrence or progression. Researchers will measure disease-free survival from the time of randomization until recurrence, progression, or death over approximately four years. Additional assessments include quality of life questionnaires, adverse events monitoring, and survival outcomes. Participants are followed closely with various evaluations throughout the study duration.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Researchers are evaluating the combination of JSB462 luxdegalutamide with abiraterone compared to an androgen receptor pathway inhibitor ARPI, which includes abiraterone or enzalutamide, in adult males with metastatic hormone-sensitive prostate cancer mHSPC. This Phase II study aims to assess the effectiveness and safety of two doses of JSB462 100 mg and 300 mg daily combined with abiraterone and to select the recommended dose for future Phase III trials. The study will analyze overall treatment response, safety, tolerability, and pharmacokinetics. Participants will undergo a screening period of 28 days before starting treatment. During treatment, they will receive daily oral doses of JSB462 at either 100 mg or 300 mg combined with abiraterone 1000 mg, or they will receive abiraterone 1000 mg or enzalutamide 160 mg alone. Treatment continues until disease progression, unacceptable side effects, death, or decision by the participant or investigator. After treatment ends, there is a 30-day safety follow-up visit, followed by a long-term follow-up period to collect ongoing safety, efficacy, and survival information until the study concludes. Throughout the study, participants will have regular assessments including prostate-specific antigen PSA levels, imaging scans, adverse event monitoring, dose adjustments, and pharmacokinetic sampling. Patient-reported outcomes and various survival and response rates will be evaluated up to approximately 83 months. Safety follow-up visits occur about 30 days after treatment stops, and long-term monitoring continues until the studys end, ensuring comprehensive data collection on treatment effects and participant well-being.

This research aims to evaluate the use of digital tools in dentistry to improve the detection of dental conditions in adults. It compares the standard real-life examination by practitioners, which combines clinical and radiographic assessments, with examinations based on imaging results from digital devices. The study follows up on previous research that provided recent insights into adult patients oral health and care needs. The study involves digital imaging technologies such as intraoral scanners optical impression cameras, panoramic radiography orthopantomogram, and Cone Beam Computed Tomography CBCT. These tools provide 3D images and detailed views of dental structures, potentially offering more systematic and rapid clinical data collection. Radiographs are only performed when medically justified, and there are no deviations from standard care. Participants attend a single study visit where data is collected through clinical examination and imaging results. Researchers will assess various dental conditions, including the number of decayed, missing, or filled teeth, the extent and location of carious and wear lesions, dental restorations, periodontal involvement, and endodontic status. The study focuses on improving the quality and completeness of diagnostic information to support better treatment planning.

Researchers are evaluating the effectiveness and safety of combining pembrolizumab and capecitabine as a post-operative treatment for patients with triple negative breast cancer TNBC who have residual disease after receiving neoadjuvant chemotherapy with pembrolizumab. This Phase II trial aims to measure invasive disease-free survival over two years in this patient group, comparing the investigational treatment to a standard care cohort treated with pembrolizumab alone. Participants in the experimental arm will receive pembrolizumab at a fixed dose of 200 mg intravenously every three weeks for a total of nine cycles during the adjuvant phase. Capecitabine tablets will be taken orally at 1250 mgm twice daily for 14 days followed by 7 days off, repeated for eight cycles, with dose reduction during radiotherapy if needed. Local radiotherapy will be given as per standard practice when indicated. An external cohort receiving standard care pembrolizumab after surgery will be observed for comparison. During the study, participants will undergo assessments to monitor survival outcomes including invasive disease-free survival, overall survival, and distant disease-free survival for up to 3.5 years. Safety will be evaluated by tracking acute and late toxicities throughout the study period. Participants will have laboratory tests, tumor tissue analysis, and clinical examinations as part of their follow-up. The trial runs until August 2028 and includes regular visits and monitoring to evaluate treatment effects and safety.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

This research aims to compare the cost-effectiveness of focal high-intensity focused ultrasound F-HIFU treatment versus radical prostatectomy RP in men with favorable intermediate risk localized prostate cancer. The study focuses on patients with non-treated prostate cancer characterized by specific Gleason scores and tumor visibility on MRI, evaluating both treatments from a healthcare system perspective. It is a randomized, pragmatic clinical trial conducted across multiple centers, aiming to provide insights into cancer control and side effect profiles such as urinary, sexual, and digestive outcomes. Participants will be randomly assigned to receive either F-HIFU using the Focal-Oneae device under local or general anesthesia or undergo a radical prostatectomy performed via open, laparoscopic, or robot-assisted surgery under general anesthesia. Randomization is stratified by center and initially equal but later adjusted to a 21 ratio favoring F-HIFU. Treatment is followed by regular monitoring up to 48 months, with data collection enhanced using national health databases to assess costs, mortality, and cancer control without additional patient visits. During the study, men will undergo assessments including urinary and sexual function evaluations, quality of life questionnaires, and survival monitoring at multiple timepoints up to 48 months. The primary outcome focuses on the cost-utility ratio at 24 months, with secondary outcomes including survival rates, preserved life costs, and treatment-related quality of life. Participants are closely followed through clinical visits and data linkage, ensuring comprehensive evaluation of both treatment approaches over time.