NCT06396910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 30, 2024

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Localize immune transcripts in the pulmonary lessions of sarcoidosis and tuberculosis patients. This is done in biopsies from pathological libraries.

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Related 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 granulomas. Front Immunol. 2024 Feb 7;14:1332733. doi: 10.3389/fimmu.2023.1332733. eCollection 2023.

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin blocks of lung tissues obtained for diagnostic purposes

MeSH Terms

Conditions

TuberculosisSarcoidosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 2, 2024

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

July 1, 2023

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations