San Vicente De Barakaldo

Researchers are evaluating the use of personalized, dynamic titanium prostheses made with 3D printing to reconstruct the chest wall after tumor removal or severe trauma. This study addresses the challenges of traditional rigid reconstruction methods that can cause pain or breathing difficulties by testing implants designed to mimic natural rib movement, potentially improving function and comfort. The study is a multicenter, ambispective registry collecting both retrospective and prospective data across major Spanish hospitals. The treatment involves creating a custom 3D-printed titanium prosthesis based on preoperative CT scans, manufactured using titanium alloy powder. During surgery, the prosthesis is implanted and anchored to the ribs or sternum to restore chest wall integrity while preserving natural dynamics. The study includes retrospective cases and prospective enrollment over 24 months, with follow-up evaluations at discharge, 1 month, 6 months, and 12 months post-surgery. Participants will undergo assessments including pulmonary function tests, pain scales, imaging like X-rays and CT scans, and quality of life questionnaires. Data is securely stored and anonymized in a centralized database compliant with European data protection laws. The primary outcomes measure changes in lung function parameters over one year. Participants can withdraw at any time, and the study aims to improve prosthesis design and surgical practices through comprehensive monitoring and analysis.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating the reactogenicity, safety, and immune response of two doses of PED-HZsu, GlaxoSmithKlines vaccine candidate, for preventing Herpes Zoster in immunocompromised children aged 1 to 17 years who have had a kidney transplant. This Phase 12 study focuses on pediatric renal transplant recipients to understand how the vaccine performs in this vulnerable group. Participants are divided by age and treatment into four groups children aged 12 to 17 receiving the vaccine, similar-aged children receiving standard care without the vaccine, children aged 1 to 11 receiving the vaccine, and the youngest group receiving standard care. Vaccinated groups receive two intramuscular doses of PED-HZsu in the deltoid muscle on day 1 and one month later. The younger age group enrollment is staggered, starting after safety data from the older group is reviewed. During the study, participants are monitored closely for local and general adverse events within seven days after each vaccination, as well as unsolicited adverse events and serious safety concerns up to two months post-vaccination. Researchers measure antibody levels one month after the second dose to assess immune response. Follow-up continues up to 13 months to track serious events, kidney transplant rejection, and occurrence of Herpes Zoster. The study includes careful assessment of seizures and other potential side effects related to the vaccine.

Researchers are evaluating the efficacy of perioperative dostarlimab compared with the standard of care in participants with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability dMMRMSI-H. This phase 3, open-label, randomized study focuses on these specific colon cancer patients to assess if dostarlimab can improve outcomes compared to current treatments. Participants are randomly assigned to receive either dostarlimab before and after surgery or the standard of care treatments, which include FOLFOX or CAPEOX chemotherapy or post-surgery observation. Dostarlimab is given as monotherapy during the perioperative period. The study carefully monitors participants for up to approximately 5 years to evaluate long-term effects. During the trial, participants undergo regular assessments including event-free survival reviewed by blinded independent central review, overall survival, and pathological response evaluations. Safety is closely monitored by tracking adverse events, immune-related effects, and serum concentrations of dostarlimab across treatment cycles. The study involves frequent follow-ups to understand treatment impact and ensure participant well-being throughout the extended observation period.