The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential information 1. on the role of the host in the mechanisms associated to the generation and evolution of active TB and 2. about future diagnostic and/or prognostic biomarkers of TB disease. All this information could be used for patients stratification and/or to design new therapeutic strategies.
Study Type
OBSERVATIONAL
Enrollment
192
Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine
National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia
Description of Clinical and Epidemiological Data of the TB patients enrolled
for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc
Time frame: at baseline
Description of the Histopathological characteristics of the TB lesions of TB patients enrolled
for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc
Time frame: at baseline
Obtention of a genic-proteomic profile of TB lesions tissues which correlate to the histopathology of the granulomas and/or the clinic-pathological features of TB patients
only for Prospective Substudy; descriptive analysis, correlation with histopathological characteristics of TB lesions and with clinical and epidemiological data of TB patients
Time frame: at baseline
Change in Immunological responses
only for Prospective Substudy. Immunological responses will be measured 2.1.3. Identification of biomarkers in blood at protein level in blood and urine; validation in tissue and blood of genic biomarkers secreted (ELISA, qPCR, immunohistochemistry).
Time frame: at baseline; and at the moment of discharge, an average of at day 15 post-enrollment
Change in Health Quality of Life Measurements
measured with Health Quality of Life Questionnaires; only for Prospective Substudy
Time frame: at baseline (before surgery) and through study completion, an average of 1 year
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