Clinical trial NCT05164757: Female Asian Nonsmoker Screening Study
Official title: Female Asian Nonsmoker Screening Study (FANSS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of Asian/Asian continent ancestry and ethnic groups are eligible for this trial.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test
timeFrame: Screening (Day -28 to -1)
measure: Number of Participants who undergo initial LDCT
timeFrame: Visit 2 (Day 30 +/- 7)
Secondary outcomes:
measure: Number of diagnoses of lung cancer
timeFrame: Visit 2 (Day 30 +/- 7)
measure: Number of diagnoses of lung cancer
timeFrame: Visit 4 (Day 365 +/- 14)
measure: Number of diagnoses of lung cancer
timeFrame: Visit 6 (day 730 +/- 14)
measure: Detection rate of Incidental thyroid nodules
timeFrame: Visit 2 (Day 30 +/- 7)
measure: Detection rate of Incidental thyroid nodules
timeFrame: Visit 4 (Day 365 +/- 14)
measure: Detection rate of Incidental thyroid nodules
timeFrame: Visit 6 (day 730 +/- 14)
measure: Detection rate of Incidental coronary artery disease
timeFrame: Visit 2 (Day 30 +/- 7)
measure: Detection rate of Incidental coronary artery disease
timeFrame: Visit 4 (Day 365 +/- 14)
measure: Detection rate of Incidental coronary artery disease
timeFrame: Visit 6 (day 730 +/- 14)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Elaine Shum, MD
role: PRINCIPAL_INVESTIGATOR
References: