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Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis

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ClinicalTrials.gov Identifier: NCT03145922
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
National Jewish Health
Information provided by (Responsible Party):
Laura L. Koth, MD, University of California, San Francisco

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.

Condition or disease Intervention/treatment
Sarcoidosis Sarcoidosis, Pulmonary Other: Observational Study

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Group/Cohort Intervention/treatment
Sarcoidosis Other: Observational Study
Observational study utilizing bronchoscopy, and imaging

Healthy Controls Other: Observational Study
Observational study utilizing bronchoscopy, and imaging




Primary Outcome Measures :
  1. Epigenomic Signature of Sarcoidosis [ Time Frame: 5 years ]
    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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People living with Sarcoidosis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145922


Contacts
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Contact: Victoria Wang, BS 4154769225 victoria.wang2@ucsf.edu

Locations
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United States, California
University of California, San Francisco (Parnassus) Recruiting
San Francisco, California, United States, 94143
Contact: Victoria Wang, BS    415-476-9225    victoria.wang2@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Jewish Health

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Responsible Party: Laura L. Koth, MD, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03145922     History of Changes
Other Study ID Numbers: 15-18171
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases