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SH-TBL: Study of TB Lesions Obtained in Therapeutical Surgery

Sponsor
Fundació Institut Germans Trias i Pujol (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02715271
Collaborator
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia (Other)
192
Enrollment
1
Location
58
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: therapeutical surgery for TB

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
192 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Study of TB Lesions Obtained in Surgery: in Search of Best Biomarkers Correlating With TB Pathology, Clinical Features, MDR Cases and Prognostic
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Retrospective cohort

Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years.

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

Tuberculosis patients prospectively submitted to therapeutical surgery.

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

Outcome Measures

Primary Outcome Measures

  1. Description of Clinical and Epidemiological Data of the TB patients enrolled [at baseline]

    for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc

  2. Description of the Histopathological characteristics of the TB lesions of TB patients enrolled [at baseline]

    for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc

  3. 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 [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 Outcome Measures

  1. Change in Immunological responses [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).

  2. Change in Health Quality of Life Measurements [at baseline (before surgery) and through study completion, an average of 1 year]

    measured with Health Quality of Life Questionnaires; only for Prospective Substudy

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Center for Tuberculosis and Lung Diseases Tbilisi Georgia

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Cris Vilaplana, Senior Researcher at the Experimental Tuberculosis Unit, Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier:
NCT02715271
Other Study ID Numbers:
  • SH-TBL-1
First Posted:
Mar 22, 2016
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant

Study Results

No Results Posted as of Feb 3, 2021