Study of TB Lesions Obtained in Therapeutical Surgery

Study Overview
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Brief Summary
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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 on the role of the host in the mechanisms associated to the generation and evolution of active TB and 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.

Official Title
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Study of TB Lesions Obtained in Surgery: in Search of Best Biomarkers Correlating With TB Pathology, Clinical Features, MDR Cases and Prognostic

Conditions
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Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant

Intervention / Treatment
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* Procedure: therapeutical surgery for TB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia indicated as per clinical routine Exclusion Criteria: Non consenting to donate samples and/or data for the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years. | Procedure: therapeutical surgery for TB<br>* Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine<br>|
| Prospective cohort<br>Tuberculosis patients prospectively submitted to therapeutical surgery. | Procedure: therapeutical surgery for TB<br>* Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | at baseline (before surgery) and through study completion, an average of 1 year |