Interstitial Lung DiseaseNCT05445817
Pulmonary Care and Research Collaborative Patient Registry
An observational study of Interstitial Lung Disease, run by Pulmonary Care and Research Collaborative Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Mar 2024
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.
Who may be able to join
- People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pulmonary Care and Research Collaborative, Ltd.
Boston, Massachusetts, 02130
Aliaa Barakat, PhD, 617-895-6636, aliaa.barakat@ildcollaborative.org
Arthur Dea, BA, 617-895-9879, arthur.dea@ildcollaborative.org
About this study
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.
Read the 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.
- Conditions
- Interstitial Lung Disease
- Keywords
- 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
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Alveolitis, Extrinsic Allergic, Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and implementation of a database populated with de-identified longitudinal medical histories of interstitial lung disease patients.
Measured: Up to 18 months
Secondary outcomes (1)
Advancing the understanding of the natural course and the treatments of interstitial lung diseases.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Pulmonary Care and Research Collaborative Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Aliaa Barakat, PhD, Principal investigator, Pulmonary Care and Research Collaborative, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445817
- Sponsor's protocol ID
- ILDC-001
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Care and Research Collaborative Patient Registry
- ClinicalTrials.gov ID
- NCT05445817
- Acronym / sponsor ID
- ILDC-001
- Conditions
- Interstitial Lung Disease
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pulmonary Care and Research Collaborative LimitedUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.
Key inclusion criteria (1 listed)
- People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development and implementation of a database populated with de-identified longitudinal medical histories of interstitial lung disease patients.
Time frame: Up to 18 months
1 secondary outcome
Advancing the understanding of the natural course and the treatments of interstitial lung diseases.
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Barakat, PhD principal investigator
Pulmonary Care and Research Collaborative, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Pulmonary Care and Research Collaborative Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliaa Barakat, PhD (617-895-6636, aliaa.barakat@ildcollaborative.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and implementation of a database populated with de-identified longitudinal medical histories of interstitial lung disease patients. (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.