Study of TB Lesions Obtained in Therapeutical Surgery

Overview

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.

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: July 2025

Interventions

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

Arms, Groups and Cohorts

  • Retrospective cohort
    • Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years.
  • Prospective cohort
    • Tuberculosis patients prospectively submitted to therapeutical surgery.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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 Measures

  • 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).
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundació Institut Germans Trias i Pujol
  • Collaborator
    • National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cris Vilaplana, Senior Researcher at the Experimental Tuberculosis Unit – Fundació Institut Germans Trias i Pujol
  • Overall Official(s)
    • Cristina Vilaplana, Dr, Principal Investigator, Fundació Institut Germans Trias i Pujol (IGTP)

Citations Reporting on Results

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.

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.

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.

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.

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