Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer

NCT01982149 | Terminated

• 2 other identifiers: 1305013973Weill Cornell Medical College
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role. This study proposes to examine the genetic correlation between nasal and bronchial epithelium and to identify a patient's risk for lung cancer earlier.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Smokers; Nonsmokers

Outcome Measures

Primary Outcomes (1)

• Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis

  Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis

  One year

Study Arms (3)

Group 1

Non-smokers (n=20)

Genetic: Group 1

Group 2

Non-smokers (n=20), Smokers (n=20) and Individuals with lung cancer (n=20)

Genetic: Group 2

Group 3

Subjects with abnormalities (nodules) detected on CT (n=20)

Genetic: Group 3

Interventions

Group 1 GENETIC

Perform gene expression studies of airway epithelium to correlate findings in the gene expression of nasal bronchial epithelium

Group 1

Group 2 GENETIC

Correlate gene expression data from nasal and bronchial epithelium

Group 2

Group 3 GENETIC

Correlated nasal epithelial gene expression with the ultimate diagnosis (by biopsy or surgery)

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan area residents

You may qualify if:

• HEALTHY VOLUNTEER RESEARCH SUBJECTS
• All study subjects should be able to provide informed consent
• Males or females ages 18 years and older
• Must provide HIV informed consent
• VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
• 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; (2) chest X-rays 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/or (6) diseases of organs with known association with lung disease
• Must provide HIV informed consent

You may not qualify if:

• HEALTHY VOLUNTEER RESEARCH SUBJECTS
• Individuals not deemed in good overall health by the investigator will not be accepted into the study.
• Habitual use of drugs and/or alcohol within the past six months (Acceptable: - Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
• 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.
• Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
• Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.
• Females who are pregnant or nursing will not be accepted into the study
• VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
• Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study.
• Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
• Females who are pregnant or nursing

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and cells obtained for this study may be retained for future research with given consent.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald G Crystal, MD

  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: October 25, 2013
• First Posted: November 13, 2013
• Study Start: June 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

US (1)