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

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ClinicalTrials.gov Identifier: NCT02715271
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : February 3, 2021
Sponsor:
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 February 3, 2021
Study Start Date September 2016
Estimated Primary Completion Date July 2021   (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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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 2021
Estimated Primary Completion Date July 2021   (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
Removed Location Countries  
 
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.
Responsible Party Cris Vilaplana, Fundació Institut Germans Trias i Pujol
Study Sponsor Fundació Institut Germans Trias i Pujol
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 February 2021