Families-At-risk for Interstitial Lung Disease Study

NCT03641742 | Completed Results DMC

• 2 other identifiers: AAAR19162R01HL103676-05
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The interstitial lung diseases (ILDs) are a family of closely related lung conditions characterized by alveolar inflammation, injury, and fibrosis not due to infection or neoplasia. While previously considered to be rare, a recent nationwide study found that idiopathic pulmonary fibrosis (IPF), a fibrotic ILD with a median survival of only 3.8 years, affects nearly 0.5% of older adults in the U.S. While pirfenidone and nintedanib slow the progression of IPF, neither reverses fibrosis nor prevents progression of the disease,and no studies to date have tested interventions that prevent the development of fibrotic ILDs.

Conditions

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Keywords

Interstitial Lung Disease; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ILA (Interstitial Lung Abnormalities)

  The visual identification of the presence of ILA (Interstitial Lung Abnormalities) on CT chest scan by a thoracic radiologist.

  During imaging (up to 1 hour)

Study Arms (2)

FAR-ILD Proband Participants

There will be no interventions administered to this group, only data collection.

FAR-ILD "At-Risk" Participants

There will be no interventions administered to this group, only data collection

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with and without a diagnosis of Interstitial Lung Disease. Adult participants with a diagnosis of interstitial lung disease as per American Thoracic Society (ATS) guidelines. Adult participants with a first-degree relative with a clinical diagnosis of interstitial lung disease. Adult participants who are at least 50 years of age with a smoking history of a minimum of 1 pack per day.

You may qualify if:

• Age 35 years or older, however subjects who are 40 years old and above will undergo HRCT and subjects age 40-65 years old will be eligible to undergo bronchoscopy
• First-degree relative with one of the following clinical diagnoses:
• Idiopathic Pulmonary Fibrosis
• Idiopathic Non-Specific Interstitial Lung Disease (with fibrosis)
• Chronic Hypersensitivity Pneumonitis (with fibrosis)
• Unclassifiable Idiopathic Interstitial Pneumonia (with fibrosis)
• Patients with any ILD characterized by fibrosis on CT chest scan
• Ability to provide informed consent
• At least 50 years of age
• Smoked at least 1 pack a day for 30 years

You may not qualify if:

• Known history of interstitial lung disease
• History of illicit drug use within the past year.
• Lower respiratory tract infection in the past 90 days.
• History of chest CT scan in the past year.
• Known history of heart failure or chronic kidney or liver disease.
• Pregnancy or Lactation
• Has one of the following clinical diagnoses as per ATS guidelines:
• Idiopathic Pulmonary Fibrosis
• Idiopathic Non-Specific Interstitial Lung Disease (with fibrosis)
• Chronic Hypersensitivity Pneumonitis (with fibrosis)
• Unclassifiable Idiopathic Interstitial Pneumonia (with fibrosis)
• Patient with any ILD characterized by fibrosis on CT chest scan
• Ability to provide informed consent
• No Living 1st degree relatives.

Sponsors & Collaborators

• Columbia University: lead
• University of Washington: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Iowa: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (5)

• Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.

  PMID: 26367186 BACKGROUND

• Facciolongo N, Patelli M, Gasparini S, Lazzari Agli L, Salio M, Simonassi C, Del Prato B, Zanoni P. Incidence of complications in bronchoscopy. Multicentre prospective study of 20,986 bronchoscopies. Monaldi Arch Chest Dis. 2009 Mar;71(1):8-14. doi: 10.4081/monaldi.2009.370.

  PMID: 19522159 BACKGROUND

• Pue CA, Pacht ER. Complications of fiberoptic bronchoscopy at a university hospital. Chest. 1995 Feb;107(2):430-2. doi: 10.1378/chest.107.2.430.

  PMID: 7842773 BACKGROUND

• Jin F, Mu D, Chu D, Fu E, Xie Y, Liu T. Severe complications of bronchoscopy. Respiration. 2008;76(4):429-33. doi: 10.1159/000151656. Epub 2008 Aug 21.

  PMID: 18716395 BACKGROUND

• Rosenthal E. New York seeks to tighten rules on medical research. N Y Times Web. 1996 Sep 27:B4. No abstract available.

  PMID: 11648036 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* Tissue samples * Airway Brushings * Urine * Bronchoalveolar Lavage Fluid * Buccal swab and or saliva; only if blood is unavailable. * Blood

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Christine Kim Garcia
• Organization: Columbia University Irving Medical Center

ckg2116@cumc.columbia.edu

2123058203

Study Officials

• Christine Garcia, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frode Jensen Professor of Medicine

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: January 15, 2018
• Primary Completion: February 11, 2020
• Study Completion: July 1, 2023
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Access Criteria: De-identified data.

Locations

US (1)