Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
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
🗓️ Study Start (Actual) January 2016
🗓️ Primary Completion (Estimated) January 2021
✅ Study Completion (Estimated) January 2026
👥 Enrollment (Estimated) 45
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 5 May 2017
  • First Submitted that Met QC Criteria 5 May 2017
  • First Posted 9 May 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 May 2020
  • Last Update Posted 6 May 2020
  • Last Verified May 2020