Female Asian Nonsmoker Screening Study (FANSS)

Female Asian Nonsmoker Screening Study (FANSS)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Elaine Shum, MD; Phone Number: 212-731-6212; Email: FANSS@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Email: FANSS@nyulangone.org
      • Principal Investigator: Elaine Shum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women of Asian/Asian continent ancestry and ethnic groups are eligible for this trial.

Description

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.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of diagnoses of lung cancer	Visit 2 (Day 30 +/- 7)
Number of diagnoses of lung cancer	Visit 4 (Day 365 +/- 14)
Number of diagnoses of lung cancer	Visit 6 (day 730 +/- 14)
Detection rate of Incidental thyroid nodules	Visit 2 (Day 30 +/- 7)
Detection rate of Incidental thyroid nodules	Visit 4 (Day 365 +/- 14)
Detection rate of Incidental thyroid nodules	Visit 6 (day 730 +/- 14)
Detection rate of Incidental coronary artery disease	Visit 2 (Day 30 +/- 7)
Detection rate of Incidental coronary artery disease	Visit 4 (Day 365 +/- 14)
Detection rate of Incidental coronary artery disease	Visit 6 (day 730 +/- 14)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Elaine Shum, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-00212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to FANSS@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No