Quint Fonsegrives

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

BACKGROUND Non-muscle infiltrating bladder tumors are a cancerous pathology with an estimated incidence of 13,000 new cases/year in France. ¾ of new cases are diagnosed at a stage where the cancer is of limited extension to the urothelial mucosa and/or its underlying chorion (non-muscle-invasive bladder cancer NMIBC). The management and follow-up of NMIBCs are performed according to the best practice recommendations issued by the Cancer Committee of the French Urology Association. The risk of recurrence at 1 and 5 years for NMIBC has been estimated in clinical trials to be between 15%-61% and 31%-78%, respectively, depending on grade, stage, number, size, frequency of previous recurrence and presence of carcinoma in situ. In this context, patients should have regular endoscopic examinations to ensure the absence of tumor lesions inside their bladder. Urine cytology pathology is recommended for the detection of recurrence of NMIBC. However, the negative predictive value of this examination does not allow it to be substituted for bladder endoscopy, as the risk of not recognizing a bladder tumor, especially of low grade, is too high. To date, no urinary biomarker has been shown to be clinically useful and their use is not recommended for the non-invasive detection of endovesical tumor recurrence. Urine sampling is recommended prior to bladder endoscopy for follow-up of NMIBC to ensure urine sterility (CBEU) and to perform urine cytology in patients with high-grade NMIBC and/or carcinoma in situ. The observational study of the clinical validity of the negative and positive predictive values of the biomarkers in a population of patients followed for a bladder tumor previously characterized is able to demonstrate the possibility of postponing the realization of the cystoscopy according to the tumoral characteristics and the treatments received by the patients. OBJECTIVES The main objective of the research will be to evaluate the diagnostic performance of biomarkers available in France, performed on a urine sample and providing a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of biomarkers. The secondary objectives will be to describe the anatomopathological characteristics, the pathological history and the treatments received in the population, as well as analyze demographic and regional disparities in the treatment profiles of these diseases. MATERIAL AND METHOD When the patient is included in the study, medical data relating to the patient's pathology, including all previous treatments, will be entered into the register, as well as the name and result of the biomarker carried out before the resection (biopsy). At each follow-up endoscopic examination scheduled in the patient's personalized care plan, the investigating urologist will record its date and endoscopic findings (white light bladder fibroscopy). The name and result of the urine test will also be recorded by the urologist. The performance of the test will be evaluated from these data by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and by means of an analysis of variance (ANOVA) to explore possible differences within the test by tumor grade and stage, and according to previous endovesical treatments received. The inclusion target is 8000 patients in France over a 3-year period.

The study for each participant consists of a Screening period (28 days), a treatment period, a post-treatment safety follow-up (30 days) followed by a long-term follow-up period. During the treatment period: * JSB462 is administered from randomization, orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. * Abiraterone 1000 mg or enzalutamide 160 mg are administered from randomization, orally, daily, and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. During the post-treatment follow up period: * Safety follow-Up: After discontinuation of study treatment, all participants will be followed for at least 1 safety follow-up visit (30 days \[+/- 7 days\] after treatment discontinuation). Subsequent lines of therapy may be administered according to investigator's discretion after treatment discontinuation. * Long-term follow-up: Starts after the Safety follow-up period and lasts until the end of study. Safety, efficacy and survival information may be collected from participants during this period.

Digital technology is playing an increasingly important role in dentistry due to its ability to assist practitioners and enhance work efficiency. Among digital tools, panoramic radiography (orthopantomogram) is currently the most widely used. It provides a comprehensive image of the jaws, highlighting internal structures in 2D. As in other fields, scientific advances have made it possible to go beyond two-dimensional representations and obtain 3D images. The intraoral scanner, also known as an "optical impression camera," emerged in the mid-1980s. These devices use light to create a digital optical impression that reproduces the surface of external anatomical structures in 3D images. They improve dental practice by making impression-taking less uncomfortable for patients, saving clinical time, simplifying storage and archiving, and facilitating transmission to dental technicians when needed. This type of device is already well established in dental practices. More recently, Cone Beam Computed Tomography (CBCT), also known as digital volumetric tomography with a conical beam, has begun to develop. This 3D sectional imaging technique allows for the exploration of internal structures by adding an extra dimension. Imaging examinations provide additional information that complements the findings of the visual clinical oral examination. Together, they help the practitioner establish a diagnosis and treatment plan. Currently, visual information must be recorded manually. Collecting this data represents a significant amount of information, and the success of treatment partly depends on its quality and completeness. Given the high volume of consultations and the need for practitioners to optimize their time, it would be worthwhile to assess whether optical impressions could help systematically and quickly acquire some of this clinical data to improve patient care. Similarly, the 3D data provided by CBCT enhances the accuracy of diagnostic information. It would also be useful to evaluate the actual added value of this examination. The RESTODATA-NUM study follows on from the RESTODATA study, whose results provided recent insights into the oral health status and care needs of adult patients. The objective of this study is to compare the performance of a standard real-life examination by a practitioner-combining clinical and radiographic assessments-with an examination based on imaging results obtained using digital tools, in terms of detecting dental conditions in a sample of adult patients undergoing an oral examination at one of the participating centers. Information on the Type of Clinical Investigation: This is an observational, descriptive, and multicenter study. Based on these characteristics, the study is initially classified by the principal investigator as a Category 3 research project under the Jardé Law (Article R1121-3 of the French Public Health Code, Decree No. 2006-477 of April 26, 2006). The digital tools used in this study (intraoral scanner, panoramic radiography, and cone beam computed tomography) are routinely employed in dental practices. Radiographs will only be performed when medically justified. There will be no deviation from standard patient care, and no additional procedures will be introduced. Overview of the ReCOL Network and Participating Private Practices: The ReCOL network is a French clinical research network in dentistry, inspired by a similar model in the United States. Its goal is to involve private dental practitioners in clinical studies. Established in 2018, ReCOL has already conducted several studies, many of which are available on its website: https://recol.fr. The network operates collaboratively, with research topics discussed within the association's executive board. The idea for the RESTODATA-NUM study emerged from one of these discussions. A total of 36 dental surgeons, all equipped with the necessary tools for the study, responded positively to a call for participation sent via email to all ReCOL members. Some of these practitioners had previously participated in the RESTODATA study. Study Procedure and Data Collection: Each participant will attend a single study visit. Eligibility will be assessed by the investigating dental surgeon. The study will be offered to all patients attending a participating center for an oral examination who meet the inclusion criteria. An information letter will be provided to each patient. If no urgent care is required, patients may take up to seven days to consider participation and reschedule their appointment if desired. Upon agreement, the patient will sign a non-opposition form.

We propose to evaluate the benefit in 2-year iDFS and safety of adding capecitabine to pembrolizumab in post-operative phase of pembrolizumab-containing treatment, in the subgroup of localized TNBC patients with residual disease. An external cohort with patients treated with pembrolizumab as part of standard care after surgery, for localized TNBC without pCR after NAC, and with similar eligibility criteria, will be registered in an ambispective way, allowing comparisons between the experimental arm and this external cohort. All the centers involved in the study will participate in the registration of the needed information concerning this cohort.

Standard treatment option of intermediate risk (ISUP2) prostate cancer (PC) is either radical prostatectomy (RP) or radiation therapy (RT). An attractive option for selected patients and for the health care system would be to spare the preserved gland to decrease urinary, sexual and digestive side effects of whole-gland treatments keeping with a good cancer control. For these reasons, focal treatments have been developed in localized PC. The principal objective of the EMERHIT study is to estimate, from the health system point of view, the efficiency (cost/utility study) of focal HIFU (F-HIFU) for intermediate risk PC compared to RP (either by open, laparoscopic or robotic surgical approach) at 24 months. It will be a multicentric pragmatic clinical trial, comparative, with no insu, randomized in two parallel groups : * (1) F-HIFU treatment * (2) RP Randomization will be equal (ratio 1:1), stratified on the centers and performed maximum at 2 months before the procedure. The comparison to the SNDS data will use the NIR of the patients selected for the study. The use of the SNDS data will allow, on top of the estimation of the care cost, to increase the patient's follow-up (with no supplemental visit) and measure, at 48 months, costs, mortality rate and cancer control measures From version 4.0 of the protocol, randomisation will be adjusted to a 2:1 ratio and stratified by centre.

Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score. We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon. However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions. The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.