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Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls


Phase 2
N/A
N/A
Open (Enrolling)
Both
Lung Cancer, Precancerous Condition

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Trial Information

Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls


OBJECTIVES:

Primary

- Define the molecular and biochemical profiles of airway epithelium of smokers with no
disease, smokers with airflow obstruction and abnormal sputum cytology, and
non-smokers.

Secondary

- Assess the occurrence of abnormalities in non-smokers, smokers with no disease, smokers
with various grades of dysplasia, and smokers with lung cancer.

OUTLINE: Patients are stratified according to smoking status (smoker vs non-smoker) and
disease (no disease vs airflow obstruction and abnormal sputum cytology vs various grades of
dysplasia vs lung cancer).

Biological samples are collected and analyzed for future research studies.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- Smoker with no disease

- Smoker with airflow obstruction and abnormal sputum cytology

- Smoker with lung cancer

- Smoker with various grades of dysplasia

- Non-smoker

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Molecular and biochemical profiles

Outcome Time Frame:

Upon completion of trial

Safety Issue:

No

Principal Investigator

York E. Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

95-0413

NCT ID:

NCT00897364

Start Date:

May 2000

Completion Date:

May 2014

Related Keywords:

  • Lung Cancer
  • Precancerous Condition
  • non-small cell lung cancer
  • small cell lung cancer
  • squamous lung dysplasia
  • Lung Neoplasms
  • Precancerous Conditions

Name

Location

University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045