Early Detection of Lung Cancer

Lung Cancer Clinical Trial

Official title:

Early Detection of Lung Cancer in the Medically Underserved Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03181256
• Other study ID #: VICC THO 1730
• Secondary ID: NCI-2017-00889CA
• Status: Active, not recruiting
• Start date: December 14, 2017
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of sputum
• Biospecimen collection
Undergo collection of nasal epithelium
• Biospecimen collection
Undergo collection of buccal epithelium
• Biospecimen collection
Undergo collection of blood
• Biospecimen collection
Undergo collection of urine
• Pulmonary Function Test
Undergo pulmonary function test
• Computed Tomography (CT)
Undergo chest CT

Other:
• Laboratory Biomarker
Correlative studies

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.