Thoracic Surgery, Tuberculosis, Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary
Conditions
Brief summary
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.
Interventions
PROCEDUREtherapeutical surgery for TB
Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine
Sponsors
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
Fundació Institut Germans Trias i Pujol
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the Histopathological characteristics of the TB lesions of TB patients enrolled | at baseline | for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc |
| Description of Clinical and Epidemiological Data of the TB patients enrolled | at baseline | for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc |
| 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 | at baseline | only for Prospective Substudy; descriptive analysis, correlation with histopathological characteristics of TB lesions and with clinical and epidemiological data of TB patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Immunological responses | at baseline; and at the moment of discharge, an average of at day 15 post-enrollment | 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). |
| Change in Health Quality of Life Measurements | at baseline (before surgery) and through study completion, an average of 1 year | measured with Health Quality of Life Questionnaires; only for Prospective Substudy |
Countries
Georgia
Outcome results
None listed