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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715271
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : September 10, 2022
Sponsor:
Collaborator:
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
Information provided by (Responsible Party):
Cris Vilaplana, Fundació Institut Germans Trias i Pujol

Study Description
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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
Tuberculosis Thoracic Surgery Tuberculosis, Pulmonary Tuberculosis, Multidrug-Resistant Procedure: therapeutical surgery for TB

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 6 Months
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 : September 2016
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 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

  2. 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

  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 [ 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


Secondary Outcome Measures :
  1. 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).

  2. 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


Biospecimen Retention:   Samples With DNA

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715271


Locations
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Georgia
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
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Principal Investigator: Cristina Vilaplana, Dr Fundació Institut Germans Trias i Pujol (IGTP)
  Study Documents (Full-Text)

Documents provided by Cris Vilaplana, Fundació Institut Germans Trias i Pujol:
Study Protocol and Informed Consent Form  [PDF] April 20, 2016

More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: March 22, 2016    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (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.
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases