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NCT Number: NCT00301119

Lung Cancer Biomarkers and Screening

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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Cancer Institute at New York University Medical Center

New York, 10016, United States

Location status: Recruiting

Location contact

James J. Tsay, MD, MSc

CONTACT

[email protected]

212-598-6351

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

James J. Tsay, MD, MSc

CONTACT

[email protected]

212-598-6351

Rosemary M Schluger

CONTACT

[email protected]

212-263-0255

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

NYU Lung Cancer Biomarker Center

Acronym: NYULCBC

Important dates

Study start
2000
Primary completion
2030
Study completion
2030
First posted
Mar 10, 2006
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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