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Researchers are investigating treatments for patients with hormone receptor-positive (HR-positive), HER2-negative early-stage breast cancer who are at higher risk of relapse after surgery within the last five years. This phase II, open-label study uses a biomarker-driven approach to monitor minimal residual disease (MRD) by analyzing circulating tumor DNA (ctDNA) in blood samples. The study includes a pre-screening phase, a molecular follow-up phase with ctDNA surveillance, and an interventional treatment phase, aiming to identify patients at molecular relapse and evaluate whether early treatment can improve outcomes. Participants first enter a ctDNA surveillance phase where tumor tissue and blood samples are collected to create individualized mutation panels. Blood is tested every three months during the first year and every six months thereafter. If ctDNA is detected, patients may enter one of four treatment arms: standard treatment followed by change, giredestrant alone, giredestrant combined with abemaciclib, or giredestrant combined with inavolisib. LHRH agonists are given as appropriate for men and premenopausal women. Treatment dosing and schedules are defined, including special dosing for certain kidney function levels. The study allows arm expansions based on ctDNA response criteria. Throughout the study, patients undergo regular ctDNA assessments to monitor treatment response. Safety and disease progression are tracked with scans and clinical evaluations. After treatment, a follow-up period collects survival and new therapy information every three months until study end. The primary outcome is measuring a decrease or clearance of baseline ctDNA three months after starting treatment. Total enrollment includes 976 patients for surveillance, with 40 allocated to treatment arms initially, and potential expansion based on results.

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Researchers are evaluating vedolizumab, a medication designed to reduce inflammation and pain in the digestive system, in children and teenagers with moderate to severe Crohn's disease. This Phase 3 study focuses on checking whether participants achieve remission, where symptoms improve or disappear and endoscopy shows no inflammation. The study will enroll about 120 pediatric patients who have not responded to or tolerated standard Crohn's disease treatments. Participants will receive three vedolizumab infusions over six weeks during the Induction Period, with doses based on their weight. At Week 14, those showing clinical response will be randomly assigned to receive either a high or low dose of vedolizumab every eight weeks through Week 46 in the Maintenance Period. Doses are adjusted based on weight groups, and participants who worsen may have their dose increased. Treatment is given via intravenous infusion, and one-time corticosteroid rescue therapy is allowed if needed. Throughout the study, participants will be closely monitored for clinical remission using the Pediatric Crohn's Disease Activity Index and endoscopic response using colonoscopy scores at Week 54. Those not maintaining corticosteroid-free remission may have additional safety visits and enter a long-term follow-up lasting up to two years. Participants who complete the study may continue vedolizumab treatment in an extension study. Researchers will assess safety and effectiveness over the entire study period.

Researchers are evaluating the long-term safety of vedolizumab in children with ulcerative colitis (UC) or Crohn's disease (CD). This study is an extension of two previous parent studies involving pediatric patients with UC or CD. Its main goal is to collect safety data over an extended period for children who have already participated in the earlier studies. Participants who join the Treatment Cohort will receive vedolizumab intravenously at the same dose they had at Week 46 of the parent study. Dosing is based on weight categories, with treatment given every 8 weeks. The study continues until the participant withdraws, vedolizumab becomes commercially available for pediatric use in their country, other drug access programs start, the sponsor decides to close the study, or for up to approximately 5 years. Participants who are not eligible for the Treatment Cohort or who stopped early will be enrolled in an Observational Cohort to monitor safety events for up to about 2 years without receiving further vedolizumab treatment. Throughout the study, participants will be closely monitored for adverse events and specified safety outcomes. Those in the Treatment Cohort will have safety visits and assessments, including a final visit 18 weeks after their last dose. The Observational Cohort participants will be followed for up to 2 years to assess safety without additional treatment. This study aims to provide important long-term safety information for vedolizumab use in children with UC or CD.

Researchers are conducting an observational study called SOGUG-PRINCIS to collect and analyze data on the effectiveness of drugs recently approved for treating genitourinary tumors under routine clinical practice in Spain. This national, multicenter study includes both retrospective patient data and prospective follow-up, aiming to validate real-world outcomes compared to those reported in phase III clinical trials. The study covers cancers originating in the kidney, ureter, bladder, prostate, testicle, urethra, penis, and seminal vesicles. The study observes patients treated with drugs such as darolutamide combined with androgen deprivation therapy and docetaxel, adjuvant nivolumab after surgical removal of urothelial carcinoma, and enfortumab vedotin. All treatments follow their approved dosing and administration guidelines in standard clinical practice. New subprojects may be added as new drugs gain funding approval by the Spanish National Health System, with each subproject focusing on specific primary endpoints. Participants' involvement includes treatment decisions made independently from the study, with data collected afterward to assess outcomes. Researchers will track progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after treatment initiation. The study also serves as a registry for genitourinary cancer treatments funded nationally, supporting long-term evaluation of drug effectiveness in real-world settings.