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Early Detection of Lung Cancer

NCT03181256 — Active not recruiting, 45 participants, Vanderbilt-Ingram Cancer Center

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Early Detection of Lung Cancer in the Medically Underserved Population

RegistryNCT03181256
StatusActive not recruiting
Study typeObservational
Enrollment45 (Actual)
SponsorVanderbilt-Ingram Cancer Center (Other); collaborators: National Cancer Institute (NCI)
ConditionsLung Cancer
InterventionsBiospecimen Collection, Biospecimen collection, Pulmonary Function Test, Computed Tomography (CT), Laboratory Biomarker (Procedure, other)
Datesstart 2017-12-14, primary completion 2023-11-30, completion 2026-11-09 (estimated), first posted 2017-06-08, last updated 2026-05-05
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ScreeningProcedure: Biospecimen Collection; Procedure: Pulmonary Function Test; Procedure: Computed Tomography (CT); Other: Laboratory BiomarkerPatients 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 (Procedure): Undergo collection of sputum
  • Biospecimen collection (Procedure): Undergo collection of nasal epithelium
  • Biospecimen collection (Procedure): Undergo collection of buccal epithelium
  • Biospecimen collection (Procedure): Undergo collection of blood
  • Biospecimen collection (Procedure): Undergo collection of urine
  • Pulmonary Function Test (Procedure): Undergo pulmonary function test
  • Computed Tomography (CT) (Procedure), also known as Undergo chest CT: Undergo chest CT
  • Laboratory Biomarker (Other): Correlative studies

+Outcome measures

Primary outcomes

  • Candidate biomarkers of risk or of early diagnosis [Up to 5 years.]: Will validate the performance of the candidate biomarkers of risk or of early diagnosis.

+Eligibility

Sex: All, ages: 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

+Locations (1)

FacilityCityCountryStatus
Vanderbilt-Ingram Cancer CenterNashville, TennesseeUnited States

+Investigators

My Notes