Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis

NCT03145922 | Unknown

• 1 other identifier: 15-18171
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most cases, the clinical disease course is highly variable and any organ can be affected leading to end organ damage despite currently available therapeutics that unfortunately also have numerous and potentially devastating side effects. The environmental triggers of sarcoidosis are unknown but several occupational, environmental and infectious agents have been associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent recruitment of other immune cells, and granuloma formation. Although several genetic markers have been associated with sarcoidosis, none fully explain individual susceptibility or clinical course variability, strongly implicating the environment and epigenetics. We have the ability to generate a map of the epigenetic histone modifications in immune cells via Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map of transcriptome profiles via RNA-seq. The availability of histone and transcriptional signatures defining T cell activity in sarcoidosis will help identify the specific molecular programs affected by disease processes and can become the basis for future discovery of novel biomarker diagnostics in a clinical setting.

Conditions

Sarcoidosis; Sarcoidosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Epigenomic Signature of Sarcoidosis

  Determine the epigenomic signature of specific histone post-translational modifications associated with CD4+ T cell skewing and activity in sarcoidosis at the site of organ involvement via Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and bronchoalveolar lavage (BAL).

  5 years

Study Arms (2)

Sarcoidosis

Other: Observational Study

Healthy Controls

Other: Observational Study

Interventions

Observational Study OTHER

Observational study utilizing bronchoscopy, and imaging

Healthy Controls; Sarcoidosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with Sarcoidosis.

You may qualify if:

• Between the ages of 18 and 85
• Diagnosis of sarcoidosis confirmed by either biopsy or by manifestations consistent with acute sarcoidosis in absence of other known diagnosis.
• Have a suspected diagnosis of sarcoidosis and is scheduled to undergo a biopsy procedure to confirm a diagnosis of sarcoidosis.
• Able to tolerate and willing to undergo study procedures

You may not qualify if:

• Current cigarette smoking or smoking within six months prior to the study
• Currently or recently (\<6months) on immunosuppressive therapy
• Pregnancy
• Patient inability to participate in the study, such as undergo venipuncture and or BAL

Sponsors & Collaborators

• National Jewish Health: lead
• University of California, San Francisco: collaborator
• University of Iowa: collaborator

Study Sites (1)

University of California, San Francisco (Parnassus)

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Sarcoidosis, Pulmonary

Interventions

Observation

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Victoria Wang, BS

CONTACT

4154769225; victoria.wang2@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

US (1)