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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02715271
Other study ID # SH-TBL-1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2016
Est. completion date July 2025

Study information

Verified date February 2024
Source Fundació Institut Germans Trias i Pujol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 192
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Georgia National Center for Tuberculosis and Lung Diseases Tbilisi

Sponsors (2)

Lead Sponsor Collaborator
Fundació Institut Germans Trias i Pujol National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

Country where clinical trial is conducted

Georgia, 

References & Publications (4)

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; — View Citation

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, Vil — View Citation

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'Garr — View Citation

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 Tu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change in Immunological responses 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
Secondary Change in Health Quality of Life Measurements measured with Health Quality of Life Questionnaires; only for Prospective Substudy at baseline (before surgery) and through study completion, an average of 1 year
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