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Evaluation of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through an IPF Registry

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ClinicalTrials.gov Identifier: NCT00212511
Recruitment Status : Withdrawn (Pending more information from PI)
First Posted : September 21, 2005
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to create a database of demographics and samples in idiopathic pulmonary fibrosis.

Condition or disease
Idiopathic Pulmonary Fibrosis

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Patients With Idiopathic Pulmonary Fibrosis Through an IPF Registry
Study Start Date : November 2004
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018


Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Determine cellular and molecular determinants of IPF [ Time Frame: Long-Term ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with interstitial lung disease.
Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

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): NCT00212511


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Rany Condos, MD NYU School of Medicine, Division of Pulmonary and Critical Care Medicine
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00212511     History of Changes
Other Study ID Numbers: 10386-02 A
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data has not been analyzed yet.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial