Early Detection of Lung Cancer

NCT ID: NCT03181256

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-14

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of sputum

Biospecimen collection

Intervention Type PROCEDURE

Undergo collection of nasal epithelium

Biospecimen collection

Intervention Type PROCEDURE

Undergo collection of buccal epithelium

Biospecimen collection

Intervention Type PROCEDURE

Undergo collection of blood

Biospecimen collection

Intervention Type PROCEDURE

Undergo collection of urine

Pulmonary Function Test

Intervention Type PROCEDURE

Undergo pulmonary function test

Computed Tomography (CT)

Intervention Type PROCEDURE

Undergo chest CT

Laboratory Biomarker

Intervention Type OTHER

Correlative studies

Interventions

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Biospecimen Collection

Undergo collection of sputum

Intervention Type PROCEDURE

Biospecimen collection

Undergo collection of nasal epithelium

Intervention Type PROCEDURE

Biospecimen collection

Undergo collection of buccal epithelium

Intervention Type PROCEDURE

Biospecimen collection

Undergo collection of blood

Intervention Type PROCEDURE

Biospecimen collection

Undergo collection of urine

Intervention Type PROCEDURE

Pulmonary Function Test

Undergo pulmonary function test

Intervention Type PROCEDURE

Computed Tomography (CT)

Undergo chest CT

Intervention Type PROCEDURE

Laboratory Biomarker

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Undergo chest CT

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Eric Grogan

Associate Professor of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Grogan, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-00889

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA152662

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VICC THO 1730

Identifier Type: -

Identifier Source: org_study_id

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