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Active, Not Recruiting

NCT Number: NCT05164757

Female Asian Nonsmoker Screening Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test

    Time frame: Screening (Day -28 to -1)

  2. Number of Participants who undergo initial LDCT

    Time frame: Visit 2 (Day 30 +/- 7)

Secondary outcomes

  1. Number of diagnoses of lung cancer

    Time frame: Visit 2 (Day 30 +/- 7)

  2. Number of diagnoses of lung cancer

    Time frame: Visit 4 (Day 365 +/- 14)

  3. Number of diagnoses of lung cancer

    Time frame: Visit 6 (day 730 +/- 14)

  4. Detection rate of Incidental thyroid nodules

    Time frame: Visit 2 (Day 30 +/- 7)

  5. Detection rate of Incidental thyroid nodules

    Time frame: Visit 4 (Day 365 +/- 14)

  6. Detection rate of Incidental thyroid nodules

    Time frame: Visit 6 (day 730 +/- 14)

  7. Detection rate of Incidental coronary artery disease

    Time frame: Visit 2 (Day 30 +/- 7)

  8. Detection rate of Incidental coronary artery disease

    Time frame: Visit 4 (Day 365 +/- 14)

  9. Detection rate of Incidental coronary artery disease

    Time frame: Visit 6 (day 730 +/- 14)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Female Asian Nonsmoker Screening Study (FANSS)

Acronym: FANSS

Important dates

Study start
2021
Primary completion
2035
Study completion
2035
First posted
Dec 21, 2021
Registry last updated
Jun 29, 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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