NCT01151527

Brief Summary

We hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 9, 2015

Status Verified

June 1, 2010

Enrollment Period

2.8 years

First QC Date

June 25, 2010

Last Update Submit

September 8, 2015

Conditions

Study Arms (1)

Sporadic (idiopathic) or familial interstitial pneumonia

We are recruiting patients with Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias that occur sporadically or familial (2 or more affected individuals in a family). Participation can be done by mail or visiting Duke University Medical Center (Durham, NC)or National Jewish Health (Denver, CO).

Eligibility Criteria

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

We are recruiting patients with Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias that occur sporadically or familial (2 or more affected individuals in a family).

You may qualify if:

  • Sporadic cases of Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias.
  • Family members ( with or without clinical disease) with a family history of pulmonary fibrosis.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tubes of blood will be drawn from the subject to extract RNA and DNA for laboratory purposes. Lung biopsy tissue (pathology slides) may be requested for specimen processing. Also Bronchoscopy fluid may be requested.

MeSH Terms

Conditions

Idiopathic Interstitial Pneumonias

Condition Hierarchy (Ancestors)

Idiopathic Pulmonary FibrosisPulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mark P Steele, MD

    Duke University

    PRINCIPAL INVESTIGATOR
  • David A Schwartz, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 28, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 9, 2015

Record last verified: 2010-06

Locations