Study of TB Lesions Obtained in Therapeutical Surgery (SH-TBL)

• ClinicalTrials.gov Identifier: NCT02715271
• Recruitment Status: Active, not recruiting
• First Posted: March 22, 2016
• Last Update Posted: September 10, 2022
• Sponsor: Fundació Institut Germans Trias i Pujol
• Collaborator: National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
• Information provided by (Responsible Party): Cris Vilaplana, Fundació Institut Germans Trias i Pujol

Tracking Information

• First Submitted Date: March 2, 2016
• First Posted Date: March 22, 2016
• Last Update Posted Date: September 10, 2022
• Study Start Date: September 2016
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2016)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 16, 2016)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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. 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.

• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: 6 Months

Biospecimen

Retention:   Samples With DNA

Description:

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

• Sampling Method: Non-Probability Sample
• Study Population: Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia

Condition

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

Intervention

Procedure: therapeutical surgery for TB

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

Study Groups/Cohorts

• Retrospective cohort
  Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years.
  Intervention: Procedure: therapeutical surgery for TB
• Prospective cohort
  Tuberculosis patients prospectively submitted to therapeutical surgery.
  Intervention: Procedure: therapeutical surgery for TB

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 16, 2018): 192
• Original Estimated Enrollment (submitted: March 16, 2016): 150
• Estimated Study Completion Date: July 2023
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Georgia

Administrative Information

• NCT Number: NCT02715271
• Other Study ID Numbers: SH-TBL-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Data obtained will be openly available through Mendeley Data, under CC BY 4.0 license.

Data set details:

Vilaplana, Cristina; Vashakidze, Sergo; Gogishvili, Shota; Nikolaishvili , Keti; Despuig, Albert; Benito, Pau; Avramopoulos, Asimakis; García, Zaira; Téllez, Erica; Sarrias, Maria Rosa (2020), "SH-TBL project dataset", Mendeley Data, V1, doi: 10.17632/knhvdbjv3r.1

• Time Frame: Once the results will be published.

• Current Responsible Party: Cris Vilaplana, Fundació Institut Germans Trias i Pujol
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundació Institut Germans Trias i Pujol
• Original Study Sponsor: Same as current
• Collaborators: National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

Investigators

• Principal Investigator: Cristina Vilaplana, Dr; Fundació Institut Germans Trias i Pujol (IGTP)

• PRS Account: Fundació Institut Germans Trias i Pujol
• Verification Date: September 2022