NCT00258544

Brief Summary

This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. The identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
50mo left

Started Oct 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress86%
Oct 2001Jul 2030

Study Start

First participant enrolled

October 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
24.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

October 30, 2025

Status Verified

September 1, 2025

Enrollment Period

28.8 years

First QC Date

November 23, 2005

Last Update Submit

October 28, 2025

Conditions

Keywords

LungFibrosisIdiopathicMicroarrayTissueBiopsy

Outcome Measures

Primary Outcomes (1)

  • Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)

    Microarray gene expression analysis involves the extraction of RNA from cells, synthesizing cDNA to hydridize to a probe array of genes, scanning signal intensities, and normalizing data to analyze probe-level expression for differential genes, Other methods of analyzing differential gene expression including Bulk RN-seq, and single cell RNA-seq will allow be employed where feasible.

    The time frame is open-ended with the goal of creating a bank of samples to support an indeterminant number of well phenotypes samples for studies of IPF.

Eligibility Criteria

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

Population includes any patients seen at the Simmons Center for Interstitial Lung Disease with the possibility of having the diagnosis of Idiopathic Pulmonary Fibrosis who's physician has ordered an open Lung Biopsy. To check for the disease also known as IPF.

You may qualify if:

  • years or age or older
  • Diagnosis of pulmonary fibrosis
  • Undergoing open lung biopsy

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Pandit KV, Corcoran D, Yousef H, Yarlagadda M, Tzouvelekis A, Gibson KF, Konishi K, Yousem SA, Singh M, Handley D, Richards T, Selman M, Watkins SC, Pardo A, Ben-Yehudah A, Bouros D, Eickelberg O, Ray P, Benos PV, Kaminski N. Inhibition and role of let-7d in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2010 Jul 15;182(2):220-9. doi: 10.1164/rccm.200911-1698OC. Epub 2010 Apr 15.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Lung Tissue from a Lung Biopsy ordered by the patients physician. Also, a blood sample may be collected at the researchers discretion as listed in the addendum consent form.

MeSH Terms

Conditions

Pulmonary FibrosisFibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin F Gibson, MD

    University of Pittsburgh - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 24, 2005

Study Start

October 1, 2001

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

October 30, 2025

Record last verified: 2025-09

Locations