Lung CancerNYULCBCNCT00301119
Lung Cancer Biomarkers and Screening
An observational study of Lung Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 3,606 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016
James J. Tsay, MD, MSc, 212-598-6351, Jun-Chieh.Tsay@nyulangone.org
About this study
Official title: NYU Lung Cancer Biomarker Center
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.
- Conditions
- Lung Cancer
- Keywords
- small cell lung cancer, non-small cell lung cancer, smoker lung cancer screening, low dose spiral CT screening
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer diagnosis as measured by CT scan findings and pathology findings annually
Measured: 07/01/2015
Secondary outcomes (1)
Precancerous lung nodules as measured by CT scan findings and pathology findings annually
Measured: 07/01/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMay 2000
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James J. Tsay, MD, MSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301119
- Sponsor's protocol ID
- 8896
- Other IDs
- NYU-H-8896-06-B
- Acronym
- NYULCBC
- Status last verified
- May 2026
- First submitted
- 8 Mar 2006
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 17934114Greenberg 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 22768300Rom 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYU Lung Cancer Biomarker Center
- ClinicalTrials.gov ID
- NCT00301119
- Acronym / sponsor ID
- NYULCBC / 8896
- Conditions
- Lung Cancer
- Keywords
- small cell lung cancer, non-small cell lung cancer, smoker lung cancer screening, low dose spiral CT screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,606 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung cancer diagnosis as measured by CT scan findings and pathology findings annually
Time frame: 07/01/2015
1 secondary outcome
Precancerous lung nodules as measured by CT scan findings and pathology findings annually
Time frame: 07/01/2015
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 17934114Greenberg 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.
- Results publication: PubMed 22768300Greenberg 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.
- Results publication: PubMed 20504322Rom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James J. Tsay, MD, MSc principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James J. Tsay, MD, MSc (212-598-6351, Jun-Chieh.Tsay@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer diagnosis as measured by CT scan findings and pathology findings annually (time frame: 07/01/2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00301119, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.