Female Asian Nonsmoker Screening Study

Female Asian Nonsmoker Screening Study (FANSS)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05164757

Acronym

FANSS

Enrollment

1041

Registered

2021-12-21

Start date

2021-03-01

Completion date

2035-06-01

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 74 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame
Number of diagnoses of lung cancer	Visit 2 (Day 30 +/- 7)
Detection rate of Incidental thyroid nodules	Visit 2 (Day 30 +/- 7)
Detection rate of Incidental coronary artery disease	Visit 2 (Day 30 +/- 7)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElaine Shum, MD

NYU Langone Health

Outcome results