NCT00301119

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,606

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started May 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2000May 2030

Study Start

First participant enrolled

May 1, 2000

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
24.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

30 years

First QC Date

March 8, 2006

Last Update Submit

May 5, 2026

Conditions

Lung Cancer

Keywords

small cell lung cancernon-small cell lung cancersmoker lung cancer screeninglow dose spiral CT screening

Outcome Measures

Primary Outcomes (1)

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

    07/01/2015

Secondary Outcomes (1)

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

    07/01/2015

Study Arms (2)

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.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 17934114RESULT

  • 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.

    PMID: 22768300RESULT

  • 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.

    PMID: 20504322RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood serum, plasma, urine, sputum, BAL, lung tissue, buccal swab

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung CarcinomaCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • James J. Tsay, MD, MSc

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James J. Tsay, MD, MSc

CONTACT

212-598-6351Jun-Chieh.Tsay@nyulangone.org

Rosemary M Schluger

CONTACT

212-263-0255rosemary.schluger@nyulangone.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 10, 2006

Study Start

May 1, 2000

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

US(1)