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RecruitingNCT00301119NYULCBCUpdated May 8, 2026

Lung Cancer Biomarkers and Screening

An observational study in Lung Cancer, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,606
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • small cell lung cancer
  • non-small cell lung cancer
  • smoker lung cancer screening
  • low dose spiral CT screening
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 3,606 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,606 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

  • r/o lung cancer

    observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery.

06

What researchers measure

Primary outcomes

  1. Lung cancer diagnosis as measured by CT scan findings and pathology findings annually

    Time frame: 07/01/2015

Secondary outcomes

  1. Precancerous lung nodules as measured by CT scan findings and pathology findings annually

    Time frame: 07/01/2015

07

Study locations

1 of 1 sites recruiting
  • NYU Cancer Institute at New York University Medical Center
    New York, New York 10016, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 17934114 ↗
  • 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. PubMed 22768300 ↗
  • 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. PubMed 20504322 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00301119
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Mar 10, 2006
Start date
May 2000
Primary completion
May 2030 (estimated)
Completion
May 2030 (estimated)
Last update
May 8, 2026

Study contacts

James J. Tsay, MD, MSc
Contact
Jun-Chieh.Tsay@nyulangone.org
212-598-6351
Rosemary M Schluger
Contact
rosemary.schluger@nyulangone.org
212-263-0255
James J. Tsay, MD, MSc
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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