Study of TB Lesions Obtained in Therapeutical Surgery

Tuberculosis Clinical Trial

— SH-TBL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02715271
• Other study ID #: SH-TBL-1
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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

External Links

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