TuberculosisNCT06396910
TB and Sarcoidosis Granuloma
An observational study of Tuberculosis and Sarcoidosis, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Tuberculosis, Sarcoidosis
- What is being tested?
- Spatial transcriptomics
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 1 Jul 2023
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis, Sarcoidosis
- Being tested
- Spatial transcriptomics
- Medical subject headings
- Tuberculosis, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial transcriptomicsDiagnostic test
Localize immune transcripts in the pulmonary lessions of sarcoidosis and tuberculosis patients. This is done in biopsies from pathological libraries.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Rottenberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396910
- Sponsor's protocol ID
- 2021-03760
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38385142
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Maping of Tuberculosis and Sarcoidosis Granuloma
- ClinicalTrials.gov ID
- NCT06396910
- Acronym / sponsor ID
- 2021-03760
- Conditions
- Tuberculosis, Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 2 May 2024 (actual)
- 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Spatial transcriptomicsLocalize immune transcripts in the pulmonary lessions of sarcoidosis and tuberculosis patients. This is done in biopsies from pathological libraries. | Diagnostic test | – |
Primary outcome
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
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 2 May 2024.
- Results publication: PubMed 38385142Carow 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sarcoidosis, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 0 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 2 May 2024. 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 Sweden. 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?
Spatial transcriptome of lung lesions of sarcoidosis and tuberculosis patients (time frame: 14 days). 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 NCT06396910, which also lists 1 linked publication.
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 2 May 2024.