NCT00843414

Brief Summary

To obtain the monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. This information will be compared to other studies in patients with lung diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1978

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1978

Completed
31 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 7, 2016

Status Verified

April 1, 2011

Enrollment Period

33.1 years

First QC Date

February 12, 2009

Last Update Submit

July 5, 2016

Conditions

Lung Disease

Keywords

EmphysemaSarcoidosisInterstitial Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages

    end of study

Secondary Outcomes (1)

  • Analysis of lung proteins present in BAL fluid

    end of study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • healthy

You may not qualify if:

  • unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43026, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood lung fluid (BAL)

MeSH Terms

Conditions

Lung DiseasesEmphysemaSarcoidosisPulmonary Fibrosis

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesLung Diseases, InterstitialFibrosis

Study Officials

  • Mark D Wewers, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Pulmonary Research

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

March 1, 1978

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 7, 2016

Record last verified: 2011-04

Locations

US(1)