NCT00362739

Brief Summary

This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,087

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

9.9 years

First QC Date

August 8, 2006

Last Update Submit

April 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Establish a set of normal ranges for various parameters in healthy individual specimens and compare to specimens from individuals with lung disease to determine parameters resulting in disease susceptibility and severity.

    5 years

Study Arms (2)

1: Lung Disease

Individuals with at least one of the following: (1)symptoms consistent with pulmonary disease; (2) chest X-ray consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) patients with diseases of organs with known association with lung disease; (7) individuals suspected of history of lung diseased based on history and/or physical examination

2: Normal Controls

Individuals without a history of lung disease

Eligibility Criteria

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

Individuals visiting the Starr-5 Pulmonary, Critical Care Unit, and 5 West floor for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease.

You may qualify if:

  • Must provide informed consent
  • Males and females, age 18 years and older
  • Lung disease proven by at least one of the following:
  • symptoms consistent with pulmonary disease
  • chest X-rays consistent with lung disease
  • pulmonary function tests consistent with lung disease
  • lung biopsy consistent with lung disease
  • family history of lung disease
  • disease of organs with know associated with lung disease
  • individuals suspected of history of lung disease based on history and/or physical examination
  • normal controls (individuals without history of lung disease) to be sampled to provide a comparison to the lung disease cohort.

You may not qualify if:

  • Drug and/or alcohol abuse within the past six months
  • Females who are pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital -- Weill Cornell Medical College of Cornell University

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

In this study, a small amount of blood for extraction of DNA for the study of the genetic basis of lung disease will be obtained from each subject. The collected blood (cells and serum) will be used for genetic testing in studies relating to the genetic material and/or gene expression, and/or studies of proteins or other substances in serum (the liquid portion of the blood after it has been allowed to clot). Because these latter protein studies will occur at a future date, the serum will be stored for use in these studies.

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveLung Diseases, InterstitialCystic FibrosisLung Neoplasms

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Ronald G Crystal, MD

    The New York Presbyterian Hospital -- Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 10, 2006

Study Start

September 1, 2005

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations