NCT00504361

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, COPD (chronic obstructive pulmonary disease), interstitial lung disease, cystic fibrosis, and lung cancer. The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

6 years

First QC Date

July 19, 2007

Last Update Submit

April 29, 2016

Conditions

Keywords

AsthmaCOPDInterstitial Lung DiseaseCystic FibrosisLung Cancersmokersnon-smokers

Outcome Measures

Primary Outcomes (1)

  • Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained.

    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; and (7) individuals suspected of history of lung diseased based on history and/or physical examination

2: Normal Control

Individuals without a history of lung disease.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals visiting the Medicine Department at the Hamad Medical Corporation, Qatar for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease. Family members of patients may be asked to participate in the study.

You may qualify if:

  • Must provide informed consent
  • Males and females, age 18 years and older
  • Evidence of lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays and/or chest CT 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; and (6) diseases of organs with known association with lung disease; and (7) individuals suspected of history of lung diseased based on history and/or physical examination

You may not qualify if:

  • Individual refuses consent.
  • Normal control group. For the purpose of this protocol, "normal" will include individuals without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease, and will be determined by the following criteria:
  • Must provide informed consent.
  • Males or females ages 18 years and older.
  • Non-smokers, ex-smokers and smokers.
  • Individual refuses consent.
  • Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Biospecimen

Retention: SAMPLES WITH DNA

This protocol is designed to collect a small amount of blood for extraction of DNA (genetic material) for the study of the genetic basis of lung disease. Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained. The goal is to find single nucleotide polymorphims (SNP), small changes in single genes that affect disease risk, to see if they correlate with lung disease.

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

    Weill Cornell Medical College, NY and Qatar

    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

July 19, 2007

First Posted

July 20, 2007

Study Start

May 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations