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Early Detection of Lung Cancer

Early Detection of Lung Cancer in the Medically Underserved Population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03181256
Enrollment
45
Registered
2017-06-08
Start date
2017-12-14
Completion date
2025-12-01
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

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.

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of sputum

PROCEDUREBiospecimen collection

Undergo collection of nasal epithelium

PROCEDUREPulmonary Function Test

Undergo pulmonary function test

PROCEDUREComputed Tomography (CT)

Undergo chest CT

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Candidate biomarkers of risk or of early diagnosisUp to 5 years.Will validate the performance of the candidate biomarkers of risk or of early diagnosis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026