Early Detection of Lung Cancer

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Lung Cancer

Treatments: Procedure: Biospecimen collection; Procedure: Pulmonary Function Test; Procedure: Biospecimen Collection; Other: Laboratory Biomarker; Procedure: Computed Tomography (CT)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03181256

VICC THO 1730

CA152662 (Other Grant/Funding Number)

NCI-2017-00889 (Registry Identifier)

Details and patient eligibility

About

This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

Full description

PRIMARY OBJECTIVES:

I. To provide screening for lung cancer in an underserved and high risk population for lung cancer.

II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.

III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.

IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.

V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.

VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).

OUTLINE:

Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.

Enrollment: 45 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years
• >= 30 pack year of smoking history
• Participant is uninsured

Exclusion criteria

• History of diagnosis/treatment of lung cancer in the past 2 years
• History of head/neck or esophageal cancer in the last 1 year
• Inability to provide informed consent

Trial design

45 participants in 1 patient group

Screening

Description:

Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records

Treatment:

Other: Laboratory Biomarker

Procedure: Computed Tomography (CT)

Procedure: Biospecimen Collection

Procedure: Pulmonary Function Test