Early Detection of Lung Cancer

NCT03181256 | Active Not Recruiting DMC

• 3 other identifiers: VICC THO 1730NCI-2017-00889CA152662
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Biospecimen collection PROCEDURE

Undergo collection of sputum

Screening

Pulmonary Function Test PROCEDURE

Undergo pulmonary function test

Screening

Computed Tomography (CT) PROCEDURE

Undergo chest CT

Also known as: Undergo chest CT

Screening

Laboratory Biomarker OTHER

Correlative studies

Screening

Eligibility Criteria

• Age: 55 Years - 80 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current or former smokers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum, nasal epithelium, buccal epithelium, blood, urine

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Eric Grogan, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Thoracic Surgery

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: December 14, 2017
• Primary Completion: November 30, 2023
• Study Completion (Estimated): November 9, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)