Study of TB Lesions Obtained in Therapeutical Surgery (SH-TBL)

February 29, 2024 updated by: Cris Vilaplana, Fundació Institut Germans Trias i Pujol

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline
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
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
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
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at baseline; and at the moment of discharge, an average of at day 15 post-enrollment
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
at baseline (before surgery) and through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

Investigators

  • Principal Investigator: Cristina Vilaplana, Dr, Fundació Institut Germans Trias i Pujol (IGTP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimated)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-TBL-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained will be openly available through Mendeley Data, under CC BY 4.0 license.

Data set details:

Vilaplana, Cristina; Vashakidze, Sergo; Gogishvili, Shota; Nikolaishvili , Keti; Despuig, Albert; Benito, Pau; Avramopoulos, Asimakis; García, Zaira; Téllez, Erica; Sarrias, Maria Rosa (2020), "SH-TBL project dataset", Mendeley Data, V1, doi: 10.17632/knhvdbjv3r.1

IPD Sharing Time Frame

Once the results will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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