Nashville Early Diagnosis Lung Cancer Project

NCT01475500 | Active Not Recruiting DMC

• 2 other identifiers: VICC THO 1078U01CA152662
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To compare candidate biomarkers over time among participants who did and did not develop lung cancer

  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.

  at baseline and yearly to year 5

Secondary Outcomes (3)

• To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions.

  at baseline and yearly to year 5

• 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)

• To describe patients eligible for future chemoprevention clinical trials.

  at year 5

Study Arms (1)

Screening

These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed 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

Interventions

Sputum sample PROCEDURE

This is a collection of sputum (mucous) you cough up. Three morning samples will be collected at one time. Sputum will be collected at baseline, year 1, year 2 and year 5.

Screening

Pulmonary function tests PROCEDURE

A series of different breathing tests designed to measure lung function and to determine the presence or absence of chronic obstructive pulmonary disease will be performed at baseline.

Screening

Computerized tomography (CT) scan of the chest RADIATION

A CT scan uses x-rays to take detailed pictures of the chest. Performed at baseline, year 2 and year 5. If nodules are present, CT scans will be performed every 3 months for the first year of the study.

Screening

Buccal epithelium collection OTHER

Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.

Screening

Nasal brushings PROCEDURE

A cytobrush is used to remove cells on the surface of the inside of the nose. Samples will be collected at baseline and yearly to year 5.

Screening

Bronchoscopy PROCEDURE

A flexible tube with a light and a camera will be inserted through the nose or mouth, and into the lungs to look at the airway. Bronchial tissue will be obtained.

Screening

Bronchoalveolar lavage PROCEDURE

During a bronchoscopy, a flexible tube with a light and a camera is passed through the mouth or nose into the lungs and fluid is squirted into a small part of the lung and collected for examination. Bronchoscopies will be performed at baseline and at year 5.

Screening

Blood sample collection PROCEDURE

A venous blood sample will be collected for testing of biomarkers and other relevant tests. Blood will be taken at baseline and yearly to year 5.

Screening

Urine sample PROCEDURE

Urine will be collected for routine urine tests at baseline and yearly to year 5.

Screening

Questionnaire-data collection PROCEDURE

A questionnaire about the patient's health, medical, and smoking history. Administered at baseline and yearly to year 5. Data will be taken from patient interviews and from the medical record.

Screening

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

By physician referral, medical professional referral or self-referral

You may qualify if:

• 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

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

Sponsors & Collaborators

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

Study Sites (2)

Veterans Administration

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University, Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 33400907 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Sputum, Blood, Urine, Nasal brushings, Buccal cells, Bronchical washings, Bronchioalveolar lavage brushings, Endobronchial biopsies

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Respiratory Physiological Phenomena; Bronchoscopy; Bronchoalveolar Lavage

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; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Therapeutic Irrigation; Investigative Techniques

Study Officials

• Eric Grogan, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 21, 2011
• Study Start: April 1, 2011
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

US (2)