Clinical trial NCT00301119: Lung Cancer Biomarkers and Screening
Official title: NYU Lung Cancer Biomarker Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: small cell lung cancer
non-small cell lung cancer
smoker lung cancer screening
low dose spiral CT screening
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2006-03-10
Enrollment: 9350
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects at risk for lung cancer and controls from community, private physician referrals, local trade unions, employee health fairs, word of mouth and print advertisements.

patient referrals from physician outpatient offices and inpatients with CT findings suspicious for lung cancer.

Brief summary: RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer.

PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.

Detailed description: OBJECTIVES:

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Screening Cohort

  * At high- or low-risk for lung cancer
  * Smoking history ≥ 20 pack years\*

    * With or without workplace exposure to asbestos
* NOTE: \* Participants with \< 20 pack years of smoking are eligible if 50 years of age or older
* Rule-Out Lung cancer group

  * 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

Primary outcomes:
measure: Lung cancer diagnosis as measured by CT scan findings and pathology findings annually
timeFrame: 07/01/2015
Secondary outcomes:
measure: Precancerous lung nodules as measured by CT scan findings and pathology findings annually
timeFrame: 07/01/2015
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Cancer Institute at New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: James J. Tsay, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.