Female Asian Nonsmoker Screening Study

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05164757
• Lead Sponsor: NYU Langone Health

Brief Summary

The study team propose to develop a database and biorepository of Asian female never smokers. This population is at increased risk for developing lung cancer but do not meet current lung cancer screening criteria. Study procedures will include up to 3 low-dose CT (LDCT) scans and a blood-based assay with the capability for early detection of cancer. Clinical, demographic and exposure history including possible WTC exposure will also be collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2033-03
• Study Completion: 2033-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Age 40-74 years
• Female
• Never Smoker defined as a lifetime exposure of less than 100 cigarettes
• Identify as from Asian descent, defined as having reported ancestry or race from the continent of Asia. Individuals with mixed heritage are eligible.

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Exclusion Criteria

• Prior history of lung cancer.
• Treatment for, or advisement by a physician of evidence of any cancer within the past five years, with the exceptions of non-melanoma skin cancer and most in-situ carcinomas based on PI discretion. (Treatment for, or evidence of, melanoma or in-situ bladder/transition cell carcinomas within the preceding five years renders the potential participant ineligible.)
• Participation in a cancer prevention trial.
• Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 15 pounds within the 12 months or unexplained hemoptysis.
• Medical or psychiatric condition precluding informed medical consent.
• Pneumonia or acute respiratory infection within 12 weeks of enrollment that was treated with antibiotics under physician supervision.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test	Screening (Day -28 to -1)
Number of Participants who undergo initial LDCT	Visit 2 (Day 30 +/- 7)

Secondary Outcome Measures

Name	Time	Method
Detection rate of Incidental coronary artery disease	Visit 6 (day 730 +/- 14)
Number of diagnoses of lung cancer	Visit 6 (day 730 +/- 14)
Detection rate of Incidental thyroid nodules	Visit 6 (day 730 +/- 14)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States