Early Detection of Lung Cancer

Early Detection of Lung Cancer in the Medically Underserved Population

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Pulmonary Function Test; Procedure: Biospecimen collection; Other: Laboratory Biomarker; Procedure: Biospecimen Collection; Procedure: Computed Tomography (CT); Procedure: Biospecimen collection; Procedure: Biospecimen collection; Procedure: Biospecimen collection

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Current or former smokers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Screening; 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	Procedure: Pulmonary Function Test; Undergo pulmonary function test; Other: Laboratory Biomarker; Correlative studies; Procedure: Biospecimen Collection; Undergo collection of sputum; Procedure: Computed Tomography (CT); Undergo chest CT; Other Names: Undergo chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Candidate biomarkers of risk or of early diagnosis	Will validate the performance of the candidate biomarkers of risk or of early diagnosis.	Up to 5 years.

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric Grogan, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): November 9, 2026

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena
• Other Study ID Numbers: VICC THO 1730; NCI-2017-00889 (Registry Identifier: NCI, Clinical Trials Reporting Program); CA152662 (Other Grant/Funding Number: National Cancer Institute (EDRN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No