TB and Sarcoidosis Granuloma

Tuberculosis Clinical Trial

Official title:

Immune Maping of Tuberculosis and Sarcoidosis Granuloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06396910
• Other study ID #: 2021-03760
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tuberculosis (TB) and sarcoidosis are both granulomatous diseases. Here we compared the immunological micro-environments of granulomas from TB and sarcoidosis patients using in situ sequencing (ISS) transcriptomic analysis and multiplexed immunolabelling of tissue sections.

Description:

Tuberculosis (TB) and sarcoidosis are diseases that are characterized by the formation of inflammatory structures called granulomas. TB is caused by infection with the bacteria Mycobacterium tuberculosis while sarcoidosis is a an inflammatory disease of unknown ethiology. We hypothesize that the localization of immune molecules in granulomas determines the the course of TB and sarcoidosis using in situ sequencing, a spatial transcriptomic technology and immunolabelling in biopsies from patients. In the project, we aim to answer the following questions: 1. How does the immune landscape differ in different TB granulomas (with/without necrosis, different histology)? 2. How does the immune landscape differ in acute (Lofgren's syndrome) and chronic (non-Lofgren's syndrome) sarcoidosis samples? 3. How does the immune landscape differ in histologically similar granulomas from TB and sarcoidosis patients? We will use in situ sequencing that can identify the exact location of 65 specific immune markers in the lung at the same time, thereby correlating defined immune landscapes with the histology, bacterial content and disease type.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

Inclusion Criteria:

Specimen were taken from patients with a confirmed diagnosis of TB based on granulomatous inflammation based on histopathological confirmation together with additional parameters such as, clinical symptoms, radiological and laboratory parameters (microscopy detection of acid-fast bacilli in sputum, M. tuberculosis culture, chest radiography, and MTB/RIF GeneXpert analysis) were included.

Sarcoidosis and TB biopsies were selected by a clinical patholologist that evaluated the ocurrence of the granulomatous lessions

Related Conditions & MeSH terms

• Granuloma
• Sarcoidosis
• Tuberculosis

Intervention

Diagnostic Test:
• Spatial transcriptomics
Localize immune transcripts in the pulmonary lessions of sarcoidosis and tuberculosis patients. This is done in biopsies from pathological libraries.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Carow B, Muliadi V, Skalen K, Yokota C, Kathamuthu GR, Setiabudiawan TP, Lange C, Scheu K, Gaede KI, Goldmann T, Pandita A, Masood KI, Pervez S, Grunewald J, Hasan Z, Levin M, Rottenberg ME. Immune mapping of human tuberculosis and sarcoidosis lung granul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial transcriptome of lung lesions of sarcoidosis and tuberculosis patients	We will detect individual mRNA molecules in patietn lessions with cellular definition and retaining the positional information	14 days