Idiopathic Pulmonary Fibrosis Registry for Future Studies | NCT00815711

Studies
Idiopathic Pulmonary Fibrosis Registry for Future Studies

NCT00815711

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Nov 8, 2021Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Lung Disease, Interstitial
Idiopathic Pulmonary Fibrosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2008Actual

Primary Completion Date

Jun 10, 2015Actual

Completion Date

Jun 10, 2015Actual

First Submitted Date

Dec 29, 2008

First Submission Date that Met QC Criteria

Dec 29, 2008

First Posted Date

Dec 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2021

Last Update Posted Date

Nov 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To establish a registry of patients for future studies of Inflammation in Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis.

Detailed Description

To establish a framework in which biologic samples and physiologic measures from patients with IPF can be longitudinally collected and evaluated. Having a bank of samples that are correlated with physiologic measures that follow patients through their course will allow the following proposed studies as well as future investigations to be efficiently carried out.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Framework	To establish a framework in which biologic samples and physiologic measures from patients with IPF can be longitudinally collected and evaluated	7 + years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any patient referred to the Interstitial Lund Disease clinic who is undergoing evaluation and or treatment for a new diagnosis of ILD. This can include patients referred for presumed pulmonary fibrosis/interstitial pneumonitis (IPF, UIP, NSIP), sarcoidosis, hypersensitivity pneumonitis, cryptogenic organising pneumonia, drug-induced, or other idiopathic ILDs.

Exclusion Criteria:

pregnancy
inability to follow study requirements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clay B Marsh, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University		Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D011658	Pulmonary Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided