Female Asian Nonsmoker Screening Study

Lung Cancer Clinical Trial

— FANSS  

Official title:

Female Asian Nonsmoker Screening Study (FANSS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164757
• Other study ID #: 20-00212
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 2033

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Elaine Shum, MD
• Phone: 212-731-6212
• Email: FANSS[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2033
• Est. primary completion date: March 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of Participants who undergo initial LDCT		Visit 2 (Day 30 +/- 7)
Secondary	Number of diagnoses of lung cancer		Visit 2 (Day 30 +/- 7)
Secondary	Number of diagnoses of lung cancer		Visit 4 (Day 365 +/- 14)
Secondary	Number of diagnoses of lung cancer		Visit 6 (day 730 +/- 14)
Secondary	Detection rate of Incidental thyroid nodules		Visit 2 (Day 30 +/- 7)
Secondary	Detection rate of Incidental thyroid nodules		Visit 4 (Day 365 +/- 14)
Secondary	Detection rate of Incidental thyroid nodules		Visit 6 (day 730 +/- 14)
Secondary	Detection rate of Incidental coronary artery disease		Visit 2 (Day 30 +/- 7)
Secondary	Detection rate of Incidental coronary artery disease		Visit 4 (Day 365 +/- 14)
Secondary	Detection rate of Incidental coronary artery disease		Visit 6 (day 730 +/- 14)