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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Age: 18Years +All Genders
849 locations
W

Actively Recruiting

Researchers are evaluating whether providing tuberculosis preventive treatment (TPT) during the "window period" can reduce new tuberculosis infections in children and adolescents who live with someone recently diagnosed with pulmonary tuberculosis. This cluster-randomized controlled trial focuses on preventing new infections by comparing immediate TPT to standard care, which only offers treatment to those already testing positive for infection. The study targets children and adolescents aged 5 to under 18 years who are household contacts of tuberculosis patients. Participants will be assigned to one of two groups. One group receives weekly doses of isoniazid and rifapentine for 12 weeks regardless of infection status at the start, while the other group receives the same treatment only if they test positive for infection at baseline. The treatment involves a 12-week course of the 3HP regimen, taken weekly. Those in the control group who test negative initially but convert to positive during follow-up also receive treatment after the 12-week period. Throughout the study, participants will undergo testing with the Interferon-Gamma Release Assay (IGRA) at enrollment and again after 12 weeks to detect new tuberculosis infections. Researchers will track the number of new infections by measuring IGRA conversions over this period. The study includes monitoring for treatment adherence and safety, with follow-up lasting at least 12 weeks. The results aim to inform better prevention strategies for tuberculosis in children and adolescents exposed in household settings.

Age: 5Years - 17YearsAll GendersPhase Not Applicable
13 locations