Suspended

Specimen Analysis for Understanding Pulmonary Fibrosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study aims to procure and analyze blood and tissue samples to understand pulmonary fibrosis in individuals with the condition, their family members, and healthy volunteers.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Pulmonary Fibrosis

+ Healthy Volunteers
+ Hermansky-Pudlak Syndrome (HPS)
From 18 to 115 Years
+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2004

See protocol details

Summary

Principal SponsorNational Human Genome Research Institute (NHGRI)
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 9, 2004Actual date on which the first participant was enrolled.

This study aims to explore the underlying causes of pulmonary fibrosis, a lung condition with an unknown origin. Researchers are focusing on analyzing various samples from individuals diagnosed with pulmonary fibrosis, their relatives who may have hereditary links to the disease, and healthy volunteers. By examining blood, genetic material, and lung tissue obtained through procedures like bronchoscopy and biopsies, the study seeks to uncover crucial insights into how this disease develops and progresses. The findings could potentially lead to better understanding and treatment options for those affected by pulmonary fibrosis. Participants in this study will provide samples such as blood and tissue, which may be collected using different medical procedures like bronchoscopy—a procedure where a doctor looks inside the lungs with a special instrument—or through biopsies, which involve taking small samples of tissue. Some samples might also be collected after lung transplants or during post-mortem examinations. The main goal is to analyze these samples to identify patterns or abnormalities that could explain the disease. While the study involves invasive procedures, especially for those with the disease or their relatives, it holds the promise of contributing significantly to medical knowledge, potentially leading to improved diagnostics and therapies.

Official TitleAnalysis of Specimens From Individuals With Pulmonary Fibrosis 
Principal SponsorNational Human Genome Research Institute (NHGRI)
Last updated: October 7, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
315 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers collect data at a single point in time, offering a snapshot of health, exposures, or conditions in a specific population. These studies are useful for understanding current patterns and prevalence.Other Ways to Collect Data
Prospective: These studies collect new data moving forward over time.
Retrospective: These studies use existing medical records or past data.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 115 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pulmonary Fibrosis
Healthy Volunteers
Hermansky-Pudlak Syndrome (HPS)
Criteria
8 inclusion criteria required to participate
Pulmonary fibrosis associated with collagen vascular diseases or autoinflammatory disorders,
Hermansky-Pudlak syndrome (diagnosed by paucity or deficiency of platelet dense bodies on whole mount electron microscopy or by genetic testing),
Pulmonary fibrosis post-COVID-19 \[i.e., pulmonary fibrosis in an individual recovering from SARS-CoV-2 infection\], or
Healthy research volunteers by history and indicated tests (individuals without history of chronic pulmonary disorder, collagen vascular disease, or bleeding disorder).

Show More Criteria

6 exclusion criteria prevent from participating
Inability to give informed consent (excluded due to exposure of unnecessary risks).
Individuals with any of the following:
Significant inhalational exposure to fibrogenic fibers or dusts or exposure to drugs associated with pulmonary fibrosis,
Uncontrolled ischemic heart disease,

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Family members of patients with pulmonary fibrosis
Group II
Healthy Volunteers
Group III
Patients with pulmonary fibrosis
Study Objectives
Primary Objectives

The objectives and specific aims of this protocol are to procure and analyze blood and cell/tissue specimens from individuals with pulmonary fibrosis, relatives of subjects with familial pulmonary fibrosis, and healthy research volunteers.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
SuspendedOne Study Center