Clinical trial NCT01475500: Nashville Early Diagnosis Lung Cancer Project
Official title: Nashville Early Diagnosis Lung Cancer Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-11-21
Enrollment: 480
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: By physician referral, medical professional referral or self-referral

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: To compare candidate biomarkers over time among participants who did and did not develop lung cancer
timeFrame: at baseline and yearly to year 5
Secondary outcomes:
measure: To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions.
timeFrame: at baseline and yearly to year 5
measure: To assess changes in prevalence and grade of pre-invasive lesions in this cohort.
timeFrame: baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months)
measure: To describe patients eligible for future chemoprevention clinical trials.
timeFrame: at year 5
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Veterans Administration
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University, Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Eric Grogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lakhani DA, Chen SC, Antic S, Muterspaugh A, Cook C, Liu N, Shujat H, Jouan S, Winston B, Fields K, Wenstrup J, Block SL, Hinton A, Miller A, Atmajoana S, Helton JT, Patel K, Balar AB, Brewer K, Nag S, Singh R, Disher A, Huerta L, Fremont R, Rickman O, Chen H, Eisenberg R, Sandler KL, Paulson A, Walker RC, Shah C, Smith GT, Landman B, Deppen S, Grogan EL, Aldrich MC, Massion PP. Establishing a Cohort and a Biorepository to Identify Biomarkers for Early Detection of Lung Cancer: The Nashville Lung Cancer Screening Trial Cohort. Ann Am Thorac Soc. 2021 Jul;18(7):1227-1234. doi: 10.1513/AnnalsATS.202004-344OC.