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

This study has been withdrawn prior to enrollment.
(Pending more information from PI)
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00212511
First received: September 13, 2005
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to create a database of demographics and samples in idiopathic pulmonary fibrosis.

Condition
Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Patients With Idiopathic Pulmonary Fibrosis Through an IPF Registry

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: November 2004
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2005
Last Updated: April 26, 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

ClinicalTrials.gov processed this record on July 27, 2017