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Completed

NCT Number: NCT02715271

Study of TB Lesions Obtained in Therapeutical Surgery

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Thoracic Surgery Tuberculosis, Multidrug-Resistant Tuberculosis, Pulmonary

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutical surgery for TB

Procedure

Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine

Primary outcomes

  1. Description of Clinical and Epidemiological Data of the TB patients enrolled

    Time frame: at baseline

    for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc

  2. Description of the Histopathological characteristics of the TB lesions of TB patients enrolled

    Time frame: at baseline

    for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc

  3. 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

    Time frame: 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 outcomes

  1. Change in Immunological responses

    Time frame: 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).

  2. Change in Health Quality of Life Measurements

    Time frame: at baseline (before surgery) and through study completion, an average of 1 year

    measured with Health Quality of Life Questionnaires; only for Prospective Substudy

Sponsors and collaborators

Lead sponsor

Fundació Institut Germans Trias i Pujol

Other

Collaborators

  • National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

Registry information

Official study title

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

Acronym: SH-TBL

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2016
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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