TB and Sarcoidosis Granuloma

April 30, 2024 updated by: Martin Rottenberg, Karolinska Institutet

Immune Maping of Tuberculosis and Sarcoidosis Granuloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We utilized retrospective historical samples of patients either with TB or sarcoidosis from the Aga Khan University Hospital Clinical Laboratories, Karachi, Pakistan (TB: n=10), the BioMaterialBank North, Research Center Borstel, Germany (sarcoidosis, n=7; TB=1) and the Karolinska University Hospital (Sarcoidosis, n=4). The FFPE samples used were originally obtained for diagnostic purposes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial transcriptome of lung lesions of sarcoidosis and tuberculosis patients
Time Frame: 14 days
We will detect individual mRNA molecules in patietn lessions with cellular definition and retaining the positional information
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-03760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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