Lung Cancer Biomarkers and Screening

Lung Cancer Clinical Trial

— NYULCBC  

Official title:

NYU Lung Cancer Biomarker Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00301119
• Other study ID #: 8896
• Secondary ID: NYU-H-8896-06-B
• Status: Recruiting
• Start date: May 2000
• Est. completion date: May 2030

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: James J. Tsay, MD, MSc
• Phone: 212-598-6351
• Email: Jun-Chieh.Tsay[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Other known NCT identifiers

• NCT00212524

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6860
• Est. completion date: May 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United States	NYU Cancer Institute at New York University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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/c — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer diagnosis as measured by CT scan findings and pathology findings annually		07/01/2015
Secondary	Precancerous lung nodules as measured by CT scan findings and pathology findings annually		07/01/2015