Learn about Research & Clinical Trials

Pulmonary Fibrosis Foundation Patient Registry

Study Purpose

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 18 years old or older. 2. Understand and sign the informed consent document. 3. ILD Diagnosis must be made / confirmed at a participating Registry center. 1. The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest. 2. If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD. 4. Anticipated additional follow up at the Registry center within one year.

Exclusion Criteria:

1. Diagnosed with: 1. Sarcoid. 2. Lymphangioleiomyomatosis (LAM) 3. Pulmonary alveolar proteinosis (PAP) 4. Cystic fibrosis (CF) 5. Amyloidosis

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02758808
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Michigan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kevin R Flaherty, MD
Principal Investigator Affiliation University of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
Additional Details

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research. Patients who meet inclusion and exclusion criteria and are being treated at a Registry site can be asked to participate. Patients will be required to read and sign an Institutional review board(IRB)-approved informed consent document prior to any Registry activity taking place. At the time of informed consent, participants will be asked to indicate if they are interested in being contacted by Registry site personnel for potential participation in future clinical trials and/or studies. Participants who opt out will not be contacted for future studies. No clinical procedures, testing, or diagnostics will be required by virtue of Registry participation. Participants will permit Registry staff to abstract clinical data obtained as part of routine clinical care in the diagnosis and treatment of ILD. These data will be entered into a web-based, electronic data capture (EDC) by the Registry staff to at regular intervals. Some of these data will be retrospective, having been collected prior to consenting for the Registry. Computed tomography (CT) images collected for diagnosis and / or treatment will be de-identified at the Registry site and uploaded to a secure server that is a 21 Code of Federal Regulations (CFR) Part 11, Good Clinical Practice (GCP), and HIPAA compliant online imaging repository. Participants will be asked to complete patient reported outcome (PRO) surveys related to ILD symptoms and quality of life at the time of enrollment and during clinical follow-up visits.Participants who are not seen for clinical follow-up within 12 months will be contacted by telephone or mail by Registry site personnel to complete the PRO measures. The University of Michigan Statistical Analysis of Biomedical and Educational Research (SABER) unit will serve as the Registry Data Coordinating Center and will manage data entered into a web based, CFR 21 Part 11 compliant electronic data capture (EDC) system by the Registry sites.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University fo Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University fo Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Vickie De Sarro

vdesarro@uabmc.edu

205-934-5573

Phoenix, Arizona

Status

Recruiting

Address

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

Site Contact

GeorgAnn Vanderjagt

georgann.vanderjagt@dignityhealth.org

602-406-3825

The University of Arizona, Tucson, Arizona

Status

Recruiting

Address

The University of Arizona

Tucson, Arizona, 85724-0001

Site Contact

Heidi Erickson, RN

herickso@email.arizona.edu

520-626-5287

Los Angeles, California

Status

Recruiting

Address

UCLA, David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Site Contact

Eileen Callahan

ecallahan@mednet.ucla.edu

310-794-2466

San Francisco, California

Status

Recruiting

Address

University of California at San Francisco

San Francisco, California, 94143-2204

Site Contact

Fizaa Ahmed

Fizaa.Ahmed@ucsf.edu

415-502-1958

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Susan Jacobs, RN, MS

ssjpulm@stanford.edu

650-725-8083

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Carol Bair

bairc@njhealth.org

303-398-1912

Yale School of Medicine, New Haven, Connecticut

Status

Recruiting

Address

Yale School of Medicine

New Haven, Connecticut, 06510-3206

Site Contact

Donna Carrano

donna.carrano@yale.edu

203-737-5061

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33138

Site Contact

Emmanuelle Simonet

esimonet@med.miami.edu

305-243-3728

Piedmont Healthcare, Austell, Georgia

Status

Recruiting

Address

Piedmont Healthcare

Austell, Georgia, 30106

Site Contact

Sheila Greene

sheila.greene@piedmont.org

770-745-1404

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Adeeb Ansari

adeeb.ansari@northwestern.edu

312-695-6021

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Site Contact

Spring Holland

sholland@bsd.uchicago.edu

773-834-4053

The University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

The University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Kimberly Lovell

klovell@kumc.edu

913-588-6067

University of Louisville, Louisville, Kentucky

Status

Recruiting

Address

University of Louisville

Louisville, Kentucky, 40202

Site Contact

Betty Henehan, RN

betty.henehan@louisville.edu

502-852-3184

Tulane University, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University

New Orleans, Louisiana, 70112

Site Contact

Sandy Ditta

sditta@tulane.edu

504-988-4040

University of Maryland Medical Center, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland Medical Center

Baltimore, Maryland, 21201

Site Contact

Jennifer McGrain

jmcgrain@medicine.umaryland.edu

410-328-1473

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University - School of Medicine

Baltimore, Maryland, 21205

Site Contact

Tianzhi Mao

tmao2@jhmi.edu

410-955-4176

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Rohan Rao

RRAO6@mgh.harvard.edu

617-724-2604

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Candace Flaherty

cflah@med.umich.edu

734-936-8301

Minneapolis, Minnesota

Status

Recruiting

Address

Regents of the University of Minnesota Twin Cities

Minneapolis, Minnesota, 55455

Site Contact

Amanda DeGrote

carl1032@umn.edu

612-626-7609

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Laura Hammel

hammel.laura@mayo.edu

507-266-1026

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110-1010

Site Contact

Hannah Perkins

hperkins@dom.wustl.edu

314-362-9919

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10030

Site Contact

Imaani Easthausen

ije2103@columbia.edu

212-342-4551

Weill Cornell Medical College, New York, New York

Status

Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

Site Contact

Elizabeth Peters

elp2018@med.cornell.edu

212-821-0971

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Elizabeth Lyda

elizabeth_lyda@urmc.rochester.edu

585-275-4861

Stony Brook University Hospital, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University Hospital

Stony Brook, New York, 11794-8172

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Rosemarie Smigla

rosemarie.smigla@dm.duke.edu

919-681-3866

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Rebecca Ingledue

rebecca.ingledue@uc.edu

513-558-0027

The Ohio State University, Columbus, Ohio

Status

Recruiting

Address

The Ohio State University

Columbus, Ohio, 43221

Site Contact

Sejal Crouser

sejal.crouser@osumc.edu

614-293-3351

Pennsylvania State University, Hershey, Pennsylvania

Status

Recruiting

Address

Pennsylvania State University

Hershey, Pennsylvania, 17033

Site Contact

Anne Dimmock

adimmock@hmc.psu.edu

717-531-5519 #284024

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19128

Site Contact

Carly D'Errico

derricoc@mail.med.upenn.edu

215-746-4219

Temple University Health System, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University Health System

Philadelphia, Pennsylvania, 19129

Site Contact

Puja Dubal

puja.dubal@tuhs.temple.edu

215-707-1610

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Site Contact

Melinda Klesen

klesenmj@upmc.edu

412-802-6860

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Amy Chamberlain

chambeam@musc.edu

843-792-3167

Vanderbilt University, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University

Nashville, Tennessee, 37232

Site Contact

James Del Greco

James.del.greco@vanderbilt.edu

615-343-7068

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Rhoda Annoh Gordon

Rhoda.AnnohGordon@utsouthwestern.edu

214-645-7108

Houston, Texas

Status

Recruiting

Address

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

Site Contact

Soma Jyothula

soma.s.jyothula@uth.tmc.edu

713-486-6728

UTHSC - San Antonio, San Antonio, Texas

Status

Recruiting

Address

UTHSC - San Antonio

San Antonio, Texas, 78253

Site Contact

Tara Garcia

garciat4@uthscsa.edu

210-617-5256

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84108

Site Contact

Lisa Weaver

lisa.weaver@hsc.utah.edu

801-587-7855

Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia Interstitial Lung Disease Clinic

Charlottesville, Virginia, 22908

Site Contact

Harriette Wheatley

hww6g@virginia.edu

434-924-9969

Inova Fairfax Hospital, Falls Church, Virginia

Status

Recruiting

Address

Inova Fairfax Hospital

Falls Church, Virginia, 22046

Site Contact

Drew Venuto

drew.venuto@inova.org

703-776-6485

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195-0001

Site Contact

Jennifer Hayes

jmhayes@u.washington.edu

206-598-4967