Study of TB Lesions Obtained in Therapeutical Surgery

Completed

• Conditions: Tuberculosis, Multidrug-Resistant; Thoracic Surgery; Tuberculosis; Tuberculosis, Pulmonary

• Registration Number: NCT02715271
• Lead Sponsor: Fundació Institut Germans Trias i Pujol

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Study Start: 2016-09
• Primary Completion: 2024-05
• Study Completion: 2024-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Center for Tuberculosis and Lung Diseases; 🇬🇪 Tbilisi, Georgia