Guilherand Granges

This research aims to explore the quality of life of women who have undergone surgery for invasive breast cancer. It focuses on how their quality of life changes throughout their care journey, especially considering their access to supportive oncological care both within and outside the healthcare facility. The study is observational and involves women who speak French and are covered by social security. Participants are assessed using various quality of life questionnaires, including FACT-B and EORTC QLQ-C30, among others. Women are grouped based on whether they seek supportive oncological care or do not receive any such care. The study monitors these groups over a 12-month period to compare changes in quality of life. During the study, participants will complete several questionnaires related to their quality of life at regular intervals up to 12 months. Researchers will collect and analyze this information to understand the impact of supportive care on patients well-being. The study excludes women with metastatic or bilateral breast cancer, those with recent other cancers, or those unable to complete questionnaires or participate fully.

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.

Researchers are studying how to adjust the dose of fluoropyrimidine chemotherapy based on uracilemia levels in patients with DPD deficiency who have gastrointestinal cancers. This phase II multicenter trial aims to find the best dose reduction strategy to reduce side effects while treating digestive cancers. The main question is which dose reduction is needed for patients with this enzyme deficiency. Participants will receive chemotherapy with doses adjusted according to their uracilemia level. Patients with low uracilemia <16 ngmL will get the full dose, while those with higher levels will receive varying dose reductions or random assignments between 25% and 50% reductions depending on their uracilemia range. Treatments include the FOLFOX or CAPOX chemotherapy regimens, given in cycles every 2 to 3 weeks. During the study, participants will visit the clinic every 2 to 3 weeks for checkups and tests to monitor side effects and treatment response. Researchers will measure the occurrence of serious blood and gastrointestinal toxicities after two treatment cycles and track dose adjustments, toxicity, and survival outcomes over several months and years. The study involves close monitoring of health and treatment effects for up to three years, depending on cancer stage.

Researchers are collecting real-life clinical data on patients who have had hip surgery using medical devices from FH ORTHO Company. This study, a Post-Market Clinical Follow-up PMCF observatory, aims to answer specific questions about the safety and performance of these devices when used as intended. It includes patients undergoing hip joint replacement or repair after trauma, covering different device versions and implant combinations. The study monitors patients who have had total hip arthroplasty, revision surgeries, or traumatology-related hip procedures using FH ORTHO devices. Patients will be followed for up to 15 years post-surgery to observe the devices long-term outcomes. Data collection is facilitated through electronic case report forms completed by surgeons and electronic patient-reported outcomes via phone, tablet, or computer. Participants will provide consent and may be monitored through regular follow-up visits and data collection over many years. Researchers will review the survival rate of the medical devices, focusing on revision rates as the main outcome measure. The study includes ongoing monitoring for up to 10 or 15 years, depending on the patients procedure, to gather comprehensive safety and performance information.

Researchers are conducting a global, single-arm, non-controlled observational study to assess the long-term performance, safety, and usability of Teknimeds range of sports surgery products. These devices, including bioabsorbable interference screws, pins, non-absorbable sutures, and anchors, are commonly used in orthopedic surgeries such as knee ligament reconstructions, shoulder repairs, and foot surgeries. This study aims to collect real-world safety and efficacy data to better understand these products behavior over time. The study involves patients undergoing orthopedic surgeries using various Teknimed devices like EUROSCREW NG, ISOFIX, SUTURLINK, ALINKS, and bioresorbable pins. Patients include those having surgeries on knee anterior and posterior cruciate ligaments, ankle, shoulder, and foot. The study collects data both retrospectively from surgeries performed since January 2016 and prospectively from patients planned for surgery with these products. Treatments are delivered as part of standard orthopedic surgical procedures. Participants will be followed according to local medical care standards, with assessments including joint function evaluation for up to 4 years and adverse event monitoring for 5 years. Secondary measures include pain levels, pain medication use, patient satisfaction, quality of life, radiological outcomes, and device usability during surgery. Data collection occurs during routine follow-ups and includes retrospective and prospective clinical information, ensuring comprehensive long-term monitoring of these orthopedic devices.

Researchers are conducting an observational and prospective multicenter study to evaluate the long-term performance and safety over 10 years of ATF Implants and Lap Mdical devices used in total hip arthroplasty or hemiarthroplasty. The study aims to collect clinical evidence on the survival rate of these hip prostheses and assess their safety and performance during this period. It also seeks feedback on the surgical instruments used for implant placement. The study follows patients before and after their hip replacement surgery using implants made by ATF Implants and Lap Mdical. Surgeons evaluate patients based on standard orthopedic surgery criteria and record any complications or adverse effects observed. The main focus is on tracking the 10-year survival rate of the implants, while secondary goals include monitoring hip joint function at multiple points before surgery, and at 6 months, 2, 5, 7, and 10 years after surgery. Participants will be followed over a 10-year period with regular assessments by the surgical team. These evaluations include clinical examinations and monitoring for any complications related to the implants or surgical instruments. The study gathers detailed data on hip joint performance and safety, helping to understand how well the implants work and last over a decade. This long-term follow-up provides important information for future patients and healthcare providers.