Study of TB Lesions Obtained in Therapeutical Surgery

NCT02715271 | Completed DMC

• 1 other identifier: SH-TBL-1
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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. 1.on the role of the host in the mechanisms associated to the generation and evolution of active TB and
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Immunological responses

  at baseline; and at the moment of discharge, an average of at day 15 post-enrollment

• Change in Health Quality of Life Measurements

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

Study Arms (2)

Retrospective cohort

Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years.

Procedure: therapeutical surgery for TB

Prospective cohort

Tuberculosis patients prospectively submitted to therapeutical surgery.

Procedure: therapeutical surgery for TB

Interventions

therapeutical surgery for TB PROCEDURE

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

Prospective cohort; Retrospective cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia indicated as per clinical routine

You may not qualify if:

• Non consenting to donate samples and/or data for the study

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia: collaborator

Study Sites (1)

National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

Location

Related Publications (5)

• Vashakidze S, Despuig A, Gogishvili S, Nikolaishvili K, Shubladze N, Avaliani Z, Tukvadze N, Casals M, Cayla JA, Cardona PJ, Vilaplana C. Retrospective study of clinical and lesion characteristics of patients undergoing surgical treatment for Pulmonary Tuberculosis in Georgia. Int J Infect Dis. 2017 Mar;56:200-207. doi: 10.1016/j.ijid.2016.12.009. Epub 2016 Dec 19.

  PMID: 28007659 RESULT

• Benito P, Vashakidze S, Gogishvili S, Nikolaishvili K, Despuig A, Tukvadze N, Shubladze N, Avaliani Z, Vilaplana C. Impact of adjuvant therapeutic surgery on the health-related quality of life of pulmonary tuberculosis patients. ERJ Open Res. 2020 Aug 31;6(3):00083-2020. doi: 10.1183/23120541.00083-2020. eCollection 2020 Jul.

  PMID: 32904577 RESULT

• Moreira-Teixeira L, Stimpson PJ, Stavropoulos E, Hadebe S, Chakravarty P, Ioannou M, Aramburu IV, Herbert E, Priestnall SL, Suarez-Bonnet A, Sousa J, Fonseca KL, Wang Q, Vashakidze S, Rodriguez-Martinez P, Vilaplana C, Saraiva M, Papayannopoulos V, O'Garra A. Type I IFN exacerbates disease in tuberculosis-susceptible mice by inducing neutrophil-mediated lung inflammation and NETosis. Nat Commun. 2020 Nov 4;11(1):5566. doi: 10.1038/s41467-020-19412-6.

  PMID: 33149141 RESULT

• Fonseca KL, Maceiras AR, Matos R, Simoes-Costa L, Sousa J, Ca B, Barros L, Fernandes AI, Mereiter S, Reis R, Gomes J, Tapia G, Rodriguez-Martinez P, Martin-Cespedes M, Vashakidze S, Gogishvili S, Nikolaishvili K, Appelberg R, Gartner F, Rodrigues PNS, Vilaplana C, Reis CA, Magalhaes A, Saraiva M. Deficiency in the glycosyltransferase Gcnt1 increases susceptibility to tuberculosis through a mechanism involving neutrophils. Mucosal Immunol. 2020 Sep;13(5):836-848. doi: 10.1038/s41385-020-0277-7. Epub 2020 Mar 13.

  PMID: 32203062 RESULT

• Moreno-Molina M, Shubladze N, Khurtsilava I, Avaliani Z, Bablishvili N, Torres-Puente M, Villamayor L, Gabrielian A, Rosenthal A, Vilaplana C, Gagneux S, Kempker RR, Vashakidze S, Comas I. Genomic analyses of Mycobacterium tuberculosis from human lung resections reveal a high frequency of polyclonal infections. Nat Commun. 2021 May 11;12(1):2716. doi: 10.1038/s41467-021-22705-z.

  PMID: 33976135 DERIVED

Related Links

• website of the Experimental Tuberculosis Unit, Fundacio Institut Germans Trias i Pujol

Biospecimen

Retention: SAMPLES WITH DNA

For the prospective substudy only: The following samples will be prospectively collected from patients undergoing therapeutical surgery: * Tissue samples from the TB lesions * plasma * whole blood for RNA studies * urine

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cristina Vilaplana, Dr

  Fundació Institut Germans Trias i Pujol (IGTP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher at the Experimental Tuberculosis Unit

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 22, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once the results will be published.

Locations

GE (1)