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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA152662 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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By physician referral, medical professional referral or self-referral
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| Name | Affiliation | Role |
|---|---|---|
| Eric Grogan, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Administration | Nashville | Tennessee | 37212 | United States | ||
| Vanderbilt University, Vanderbilt-Ingram Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33400907 | Derived | 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. |
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Sputum, Blood, Urine, Nasal brushings, Buccal cells, Bronchical washings, Bronchioalveolar lavage brushings, Endobronchial biopsies
| 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. |
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| 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. |
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| Buccal epithelium collection | Other | Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Urine sample | Procedure | Urine will be collected for routine urine tests at baseline and yearly to year 5. |
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| 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. |
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| 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. | 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. | at year 5 |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D001999 | Bronchoscopy |
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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