Clinical Trial on Lung Cancer - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3606

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: James J. Tsay, MD, MSc
Phone Number: 212-598-6351
Email: Jun-Chieh.Tsay@nyulangone.org

Study Contact Backup

Name: Rosemary M Schluger
Phone Number: 212-263-0255
Email: rosemary.schluger@nyulangone.org

Study Locations

United States
- New York
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Cancer Institute at New York University Medical Center
    - Contact:
      
      James J. Tsay, MD, MSc
      
      Phone Number: 212-598-6351
      
      Email: Jun-Chieh.Tsay@nyulangone.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung cancer diagnosis as measured by CT scan findings and pathology findings annually Time Frame: 07/01/2015	07/01/2015

Secondary Outcome Measures

Outcome Measure	Time Frame
Precancerous lung nodules as measured by CT scan findings and pathology findings annually Time Frame: 07/01/2015	07/01/2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

Principal Investigator: James J. Tsay, MD, MSc, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria