Tuberculosis Clinical Trial
— SH-TBLOfficial title:
Study of TB Lesions Obtained in Surgery: in Search of Best Biomarkers Correlating With TB Pathology, Clinical Features, MDR Cases and Prognostic
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] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Georgia | National Center for Tuberculosis and Lung Diseases | Tbilisi |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut Germans Trias i Pujol | National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia |
Georgia,
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
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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