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OpenTrials
Active, Not Recruiting

NCT Number: NCT03181256

Early Detection of Lung Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of sputum

Pulmonary Function Test

Procedure

Undergo pulmonary function test

Computed tomography (CT)

Procedure

Undergo chest CT

Other names: Undergo chest CT

Laboratory Biomarker

Other

Correlative studies

Primary outcomes

  1. Candidate biomarkers of risk or of early diagnosis

    Time frame: Up to 5 years.

    Will validate the performance of the candidate biomarkers of risk or of early diagnosis.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Early Detection of Lung Cancer in the Medically Underserved Population

Important dates

Study start
2017
Primary completion
2023
Study completion
2026
First posted
Jun 8, 2017
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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