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A5302: BioBank for Surrogate Marker Research for TB (B-SMART)
A5302 is a multi-center trial of the AIDS Clinical Trials Group (ACTG) in collaboration with the Tuberculosis Trials Consortium (TBTC).This study will be conducted at the BJ Government Medical College (BJGMC) in Pune, India. Study staff of the BJGMC will conduct the study and Johns Hopkins investigators will not have contact with participants or be involved in data collection.
The purpose of this study is to:
- Collect and store relevant biological specimens for repository biobanking to be used in future TB research to characterize and evaluate biomarkers of TB treatment response, and
- Outline the initial laboratory pilot projects, as described in the New Works Concept Sheet (NWCS) included as an appendix to the study protocol, that will use the specimens to further characterize the candidate biomarkers to be evaluated.
The sputum, serum, urine and peripheral blood mononuclear cells (PBMCs) will be collected for central TB biorepository storage from participants undergoing treatment for culture-confirmed pulmonary TB. Treatment regimens are not determined or provided as part of this study. Samples for future TB research will be submitted to and stored in either the ACTG Biomedical Research Institute (BRI) specimen repository, the Global TB Alliance CTB2 Biomarker Repository at Fisher Bioservices in the United Kingdom, or on-site as necessary.