Nashville Early Diagnosis Lung Cancer Project

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Procedure: Sputum sample; Procedure: Pulmonary function tests; Radiation: Computerized tomography (CT) scan of the chest; Other: Buccal epithelium collection; Procedure: Nasal brushings; Procedure: Bronchoscopy; Procedure: Bronchoalveolar lavage; Procedure: Blood sample collection; Procedure: Urine sample; Procedure: Questionnaire-data collection

• Registration Number: NCT01475500
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies.

The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis.

The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.

Detailed Description

It is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). The expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. All individuals benefit from clinic visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2026-10-31
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• 55 - 80 years of age
• Current smoker or former smoker. If former smoker, must have quit smoking less than 15 years ago
• >/= 30 pack year of smoking history

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
• Participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (DVT, mechanical heart valves, unstable coronary syndrome, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening	Pulmonary function tests	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Blood sample collection	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Computerized tomography (CT) scan of the chest	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Sputum sample	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Nasal brushings	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Bronchoscopy	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Urine sample	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Questionnaire-data collection	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Buccal epithelium collection	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
Screening	Bronchoalveolar lavage	These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions

Primary Outcome Measures

Name	Time	Method
To compare candidate biomarkers over time among participants who did and did not develop lung cancer	at baseline and yearly to year 5	Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly screening results will be compared in the two groups.

Secondary Outcome Measures

Name	Time	Method
To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions.	at baseline and yearly to year 5	Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for presently unknown biomarkers that occur in patients with lung cancer and in patients who do not have lung cancer but who may be at further increased risk of lung cancer.
To assess changes in prevalence and grade of pre-invasive lesions in this cohort.	baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months)	Endobronchial tissue will be examined under a microscope for presence of changes in the cells that are abnormal but which are not invasive cancer.
To describe patients eligible for future chemoprevention clinical trials.	at year 5	Inclusion criteria for those patients who, based on their biomarker profile, are at increased risk of invasive lung cancer and who may benefit from clinical trials that will study chemoprevention strategies for lung cancer.

Trial Locations

Locations (2)

Veterans Administration; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University, Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States