NCT00837668

Brief Summary

to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

6.8 years

First QC Date

February 4, 2009

Last Update Submit

June 12, 2017

Conditions

Sarcoidosis

Keywords

sarcoidosisstromal gene expressionpulmonary sarcoidosisbronchoscopy

Outcome Measures

Primary Outcomes (1)

  • To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis.

    end of study

Secondary Outcomes (1)

  • To Determine if Gene Expression Patterns Correlate With The Severity of Illness Of Sarcoidosis Patients

    end of study

Study Arms (1)

sarcoidosis

sarcoidosis patients undergoing clinical bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from sarcoidosis clinic

You may qualify if:

  • diagnosis of sarcoidosis

You may not qualify if:

  • inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

lung tissue

MeSH Terms

Conditions

SarcoidosisSarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Elliott Crouser, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

April 1, 2005

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

US(1)