Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10850 participants
OBSERVATIONAL
2000-05-31
2030-05-31
Brief Summary
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PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.
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Detailed Description
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* Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
* Identify preneoplastic cellular changes and lesions in these patients.
OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk).
Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy.
Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy.
PROJECTED ACCRUAL: A total of participants will be accrued for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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lung cancer screening cohort
observational only. no intervention. current, former and never smokers over age 50 without history of cancer, except for non melanoma skin cancer, no previous treatment with chemotherapy.
No interventions assigned to this group
r/o lung cancer
observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Referred for evaluation of suspicious nodules with 1 of the following diagnoses:
* Lung cancer
* Nonmalignant nodules (control group)
PATIENT CHARACTERISTICS:
* Not pregnant
* No prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
* Not specified
50 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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James J. Tsay, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Greenberg AK, Rimal B, Felner K, Zafar S, Hung J, Eylers E, Phalan B, Zhang M, Goldberg JD, Crawford B, Rom WN, Naidich D, Merali S. S-adenosylmethionine as a biomarker for the early detection of lung cancer. Chest. 2007 Oct;132(4):1247-52. doi: 10.1378/chest.07-0622.
Greenberg AK, Lu F, Goldberg JD, Eylers E, Tsay JC, Yie TA, Naidich D, McGuinness G, Pass H, Tchou-Wong KM, Addrizzo-Harris D, Chachoua A, Crawford B, Rom WN. CT scan screening for lung cancer: risk factors for nodules and malignancy in a high-risk urban cohort. PLoS One. 2012;7(7):e39403. doi: 10.1371/journal.pone.0039403. Epub 2012 Jul 2.
Rom WN, Goldberg JD, Addrizzo-Harris D, Watson HN, Khilkin M, Greenberg AK, Naidich DP, Crawford B, Eylers E, Liu D, Tan EM. Identification of an autoantibody panel to separate lung cancer from smokers and nonsmokers. BMC Cancer. 2010 May 26;10:234. doi: 10.1186/1471-2407-10-234.
Other Identifiers
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NYU-H-8896-06-B
Identifier Type: -
Identifier Source: secondary_id
8896
Identifier Type: -
Identifier Source: org_study_id
NCT00212524
Identifier Type: -
Identifier Source: nct_alias
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