Sarcoidosis and Immune Cells in Lung, Lymph Nodes and Blood

NCT05751447 | Recruiting

• 1 other identifier: K2019-6557
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sarcoidosis is an inflammatory disease, most commonly affecting the lungs and intrathoracic lymph nodes but can affect virtually any organ, sometimes manifesting as life threatening cardiac arrythmias. Some patients resolve spontaneously, whereas others get a chronic disease leading to for instance impaired lung function and cardiac failure. The most severe cases might need a transplantation. In the lungs, activated T cells are accumulated leading to release of cytokines, especially TNF-alpha is regarded as crucial for disease progression. Some segments of the T cell receptor and specific genes (HLA types) are connected to a resolving disease. More detailed knowledge about mechanisms why some experience a chronic disease course and others resolve spontaneously without treatment is to a large extent lacking. There is no cure, and despite treatment with immunosuppressants (often corticosteroids and cytotoxic agents), many patients experience a deteriorating disease. Aim:

1. 1.Find biomarkers to be able to early predict which patients will develop a more severe/ chronic disease course and thereby enabeling early intervention before irreversible damage.
2. 2.Predict which treatment is best for a specific patient, i.e. individualize treatment.
3. 3.Find targets for new potential therapies.

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Immune cell percentages in lung, lymph nodes and blood

  Is there a difference in frequency of different immune cells (percentage) between different compartments in clinical disease phenotypes?

  2 years

Study Arms (1)

Immune cells

EXPERIMENTAL

Lymph node puncture and/ or bronchoscopy.

Diagnostic Test: Lymph node puncture, bronchoscopy

Interventions

Lymph node puncture, bronchoscopy DIAGNOSTIC_TEST

Included patients will undergo an extra lympn node punction through oesophagus and/ or an extra bronchoscopy.

Immune cells

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspicion of sarcoidosis
• Swedish speaking
• Able to understand and approve of study protocol
• No contraindications for planned interventions

You may not qualify if:

• No suspicion of sarcoidosis
• Not Swedish-speking
• Not able to understand study protocol
• Not approving of stydy protocol
• Contraindications for planned interventions

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Sarcoidosis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Susanna Kullberg, MD

CONTACT

070-2715639; susanna.kullberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 2, 2023
• Study Start: October 1, 2019
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2034
• Last Updated: October 4, 2024

Record last verified: 2024-04

Locations

SE (1)