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Active, Not Recruiting

NCT Number: NCT01475500

Nashville Early Diagnosis Lung Cancer Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

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.

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.

Buccal epithelium collection

Other

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

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.

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.

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.

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.

Urine sample

Procedure

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

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. To assess changes in prevalence and grade of pre-invasive lesions in this cohort.

    Time frame: 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.

  3. To describe patients eligible for future chemoprevention clinical trials.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2011
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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