Pulmonary Care and Research Collaborative Patient Registry

• Sponsor: Pulmonary Care and Research Collaborative Limited (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05445817
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

The purpose of this research study is to build and maintain a registry of people with interstitial lung disease (ILD). Medical information collected for this registry may be used to advance ILD and pulmonary research and improve patient care. This is an observational registry. Participants will not receive any investigational treatments or investigational drugs as part of their participation in this registry.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease

Detailed Description

The registry will contain longitudinal medical histories of ILD patients. The creation and curation of the registry with utilize release of information services, biomedical informatics methods and human expert reviews. Among the registry's long-term goals is to utilize its data and informatics resources to study and advance ILD diagnosis and treatment. The registry will be developed with a set of capabilities to consistently, repeatedly, and economically build research-grade datasets that allow cohort development from natively unstructured and non-standard phenotypic clinical and imaging data.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pulmonary Care and Research Collaborative Patient Registry
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Outcome Measures

Primary Outcome Measures

1. Development and implementation of a database populated with de-identified longitudinal medical histories of interstitial lung disease patients. [Up to 18 months]

Secondary Outcome Measures

1. Advancing the understanding of the natural course and the treatments of interstitial lung diseases. [Up to 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Care and Research Collaborative, Ltd.	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• Pulmonary Care and Research Collaborative Limited
• Genentech, Inc.

Investigators

• Principal Investigator: Aliaa Barakat, PhD, Pulmonary Care and Research Collaborative, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pulmonary Care and Research Collaborative Limited
• ClinicalTrials.gov Identifier: NCT05445817
• Other Study ID Numbers: ILDC-001
• First Posted: Jul 6, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pulmonary Care and Research Collaborative Limited: Progressive Fibrosing Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease Associated With Systemic Sclerosis; Myositis-Associated Interstitial Lung Disease; Sarcoidosis; Hypersensitivity Pneumonitis; Pulmonary Fibrosis
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Interstitial

Study Results

No Results Posted as of Jul 19, 2022