TuberculosisSH-TBLNCT02715271
Study of TB Lesions Obtained in Therapeutical Surgery
An observational study of Tuberculosis and Thoracic Surgery, run by Fundació Institut Germans Trias i Pujol at 1 site in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary
- What is being tested?
- therapeutical surgery for TB
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteGeorgia
- Study dates
- Sep 2016to May 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia
Who may be able to join
- Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia indicated as per clinical routine
Who cannot join
- Non consenting to donate samples and/or data for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of TB Lesions Obtained in Surgery: in Search of Best Biomarkers Correlating With TB Pathology, Clinical Features, MDR Cases and Prognostic
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
- on the role of the host in the mechanisms associated to the generation and evolution of active TB and
- 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.
- Conditions
- Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
- Being tested
- therapeutical surgery for TB
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutical surgery for TBProcedure or surgery
Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years. Receives: Procedure: therapeutical surgery for TB | |
| Prospective cohort | Tuberculosis patients prospectively submitted to therapeutical surgery. Receives: Procedure: therapeutical surgery for TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
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
Measured: at baseline
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
Measured: at baseline
Secondary outcomes (2)
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).
Measured: at baseline; and at the moment of discharge, an average of at day 15 post-enrollment
Change in Health Quality of Life Measurements
measured with Health Quality of Life Questionnaires; only for Prospective Substudy
Measured: at baseline (before surgery) and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2024
- Study completionMay 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 192 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
- Responsible party
- Principal investigator, Cris Vilaplana, Fundació Institut Germans Trias i Pujol
- Investigators
- Cristina Vilaplana, Dr, Principal investigator, Fundació Institut Germans Trias i Pujol (IGTP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715271
- Sponsor's protocol ID
- SH-TBL-1
- Acronym
- SH-TBL
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2016
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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
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.
PubMed 28007659Benito 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.
PubMed 32904577Moreira-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.
PubMed 33149141Fonseca 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.
PubMed 32203062Moreno-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.
PubMed 33976135
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of TB Lesions Obtained in Surgery: in Search of Best Biomarkers Correlating With TB Pathology, Clinical Features, MDR Cases and Prognostic
- ClinicalTrials.gov ID
- NCT02715271
- Acronym / sponsor ID
- SH-TBL / SH-TBL-1
- Conditions
- Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
- Study start
- Sep 2016
- Primary completion
- May 2024 (actual)
- Study completion
- May 2024 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- on the role of the host in the mechanisms associated to the generation and evolution of active TB and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Procedure: therapeutical surgery for TBTuberculosis patients submitted to therapeutical surgery during the last 2-5 years. |
| Prospective cohort | – | Procedure: therapeutical surgery for TBTuberculosis patients prospectively submitted to therapeutical surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia
Key inclusion criteria (1 listed)
- Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia indicated as per clinical routine
Key exclusion criteria (1 listed)
- Non consenting to donate samples and/or data for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutical surgery for TBPatients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine | Procedure or surgery | Prospective cohort, Retrospective cohort |
Primary outcome
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
2 secondary outcomes
Change in Immunological responses
Time frame: at baseline; and at the moment of discharge, an average of at day 15 post-enrollment
Change in Health Quality of Life Measurements
Time frame: at baseline (before surgery) and through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 28007659Vashakidze 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.
- Results publication: PubMed 32904577Benito 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.
- Results publication: PubMed 33149141Moreira-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.
- Results publication: PubMed 32203062Fonseca 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.
- Derived from this study: PubMed 33976135Moreno-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.
- website of the Experimental Tuberculosis Unit, Fundacio Institut Germans Trias i PujolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Vilaplana, Dr principal investigator
Fundació Institut Germans Trias i Pujol (IGTP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Thoracic Surgery, run by Fundació Institut Germans Trias i Pujol at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of Clinical and Epidemiological Data of the TB patients enrolled (time frame: at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02715271, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.