NCT00212511

Brief Summary

The purpose of this study is to create a database of demographics and samples in idiopathic pulmonary fibrosis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

13.2 years

First QC Date

September 13, 2005

Last Update Submit

April 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine cellular and molecular determinants of IPF

    An IPF Registry is being established to assemble sufficient patients with IPF (especially in its earliest stage) for phase I therapeutic protocols. The Registry will incorporate demographic and clinical data for natural history studies; second, research data on physiology, high-resolution CT scan, questionnaires, and blood samples for blood banking to be collected every 6 months for prospective studies on pathophysiology; and third, response to standard therapies will be monitored to determine cellular and molecular relationships to clinical outcome and predictors of survival. This is done in order to better determine cellular and molecular determinants of IPF. This cohort will be large enough to commence a separate phase I protocol with molecular strategies of intervention.

    Long-Term

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with interstitial lung disease.

You may qualify if:

  • Male or Female greater or equal to age 18.
  • Referral by physician with the diagnosis of IPF, or interstitial lung disease (IPF considered likely).

You may not qualify if:

  • (a) Unwilling or unable to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rany Condos, MD

    NYU School of Medicine, Division of Pulmonary and Critical Care Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Data has not been analyzed yet.

Locations