An observational study in Lung Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Active, not recruiting at 2 sites in United States. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Vanderbilt-Ingram Cancer Center · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 480 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
By physician referral, medical professional referral or self-referral
Exclusion Criteria:
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
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.
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.
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.
Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.
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.
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.
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.
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 will be collected for routine urine tests at baseline and yearly to year 5.
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.
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.
Time frame: at baseline and yearly to year 5
To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions.
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.
Time frame: at baseline and yearly to year 5
To assess changes in prevalence and grade of pre-invasive lesions in this cohort.
Endobronchial tissue will be examined under a microscope for presence of changes in the cells that are abnormal but which are not invasive cancer.
Time frame: baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months)
To describe patients eligible for future chemoprevention clinical trials.
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.
Time frame: at year 5
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center