Nashville Early Diagnosis Lung Cancer Project - Full Text View

Purpose

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.

Condition	Intervention
Lung Cancer	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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Nashville Early Diagnosis Lung Cancer Project

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans Urine and Urination

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
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. [ Time Frame: baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months) ] [ Designated as safety issue: No ]
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. [ Time Frame: at year 5 ] [ Designated as safety issue: No ]
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.

Biospecimen Retention: Samples With DNA

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

Estimated Enrollment:	320
Study Start Date:	April 2011
Estimated Study Completion Date:	November 2016
Estimated Primary Completion Date:	November 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Screening These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions	Procedure: Sputum sample 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. Procedure: Pulmonary function tests 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. Radiation: Computerized tomography (CT) scan of the chest 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. Other: Buccal epithelium collection Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5. Procedure: Nasal brushings 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. Procedure: Bronchoscopy 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. Procedure: Bronchoalveolar lavage 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. Procedure: Blood sample collection 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. Procedure: Urine sample Urine will be collected for routine urine tests at baseline and yearly to year 5. Procedure: Questionnaire-data collection 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.

Groups/Cohorts

Assigned Interventions

Screening

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

Procedure: Sputum sample

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.

Procedure: Pulmonary function tests

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.

Radiation: Computerized tomography (CT) scan of the chest

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.

Other: Buccal epithelium collection

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

Procedure: Nasal brushings

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.

Procedure: Bronchoscopy

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.

Procedure: Bronchoalveolar lavage

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.

Procedure: Blood sample collection

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.

Procedure: Urine sample

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

Procedure: Questionnaire-data collection

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.

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

Ages Eligible for Study:	55 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

By physician referral, medical professional referral or self-referral

Criteria

Inclusion Criteria:

10 year Bach risk model >2.5%, (55 - 74 years of age, Current smoker with at least 25 years of smoking, at least 10 cigarettes/day, or Former smoker at least 20 pack-per-year (PPK) history of cigarette smoking total, who quit 20 years ago or less)
Plus one of the following:
Forced expiratory volume in 1 second (FEV1) <70% predicted
Or at least one first-degree relative with a diagnosis of lung cancer
Or emphysema , moderate or severe
Or history of resected lung cancer with no evidence of disease at 2 year follow up.
Or history of treated head/neck and/or esophageal cancer with no evidence of disease at 1 year post intervention.

Exclusion Criteria:

History of diagnosis/treatment of lung cancer in the past 2 years or of head/neck or esophageal cancer in the last 1 year.
Inability to provide informed consent
Chest CT within the last 12 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475500

Contacts

Contact: VICC Clinical Trials Information Program	800-811-8480
Contact: Anel Muterspaugh	615-936-4244

Locations

United States, Tennessee
Vanderbilt University, Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program 800-811-8480
Contact: Anel Muterspaugh 615-936-4244
Principal Investigator: Pierre P Massion, MD
Meharry Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Reporting Program 800-811-8480
Contact: Anel Muterspaugh 615-875-6099
Principal Investigator: Pierre P Massion, MD
Veterans Administration	Not yet recruiting
Nashville, Tennessee, United States, 37212
Contact: Sanja Antic 615-875-6099
Principal Investigator: Pierre P Massion, MD

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Pierre P Massion, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

our website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pierre P. Massion, MD, Ingram Associate Professor of Cancer Research, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT01475500 History of Changes
Other Study ID Numbers:	VICC THO 1078, U01CA152662
Study First Received:	October 18, 2011
Last Updated:	February 25, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013