Lung CancerFANSSNCT05164757
Female Asian Nonsmoker Screening Study
An observational study of Lung Cancer, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Lung Cancer
- How many people
- 1,041 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Jun 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women of Asian/Asian continent ancestry and ethnic groups are eligible for this trial.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test
Measured: Screening (Day -28 to -1)
Number of Participants who undergo initial LDCT
Measured: Visit 2 (Day 30 +/- 7)
Secondary outcomes (9)
Number of diagnoses of lung cancer
Measured: Visit 2 (Day 30 +/- 7)
Number of diagnoses of lung cancer
Measured: Visit 4 (Day 365 +/- 14)
Number of diagnoses of lung cancer
Measured: Visit 6 (day 730 +/- 14)
Detection rate of Incidental thyroid nodules
Measured: Visit 2 (Day 30 +/- 7)
Detection rate of Incidental thyroid nodules
Measured: Visit 4 (Day 365 +/- 14)
Detection rate of Incidental thyroid nodules
Measured: Visit 6 (day 730 +/- 14)
Detection rate of Incidental coronary artery disease
Measured: Visit 2 (Day 30 +/- 7)
Detection rate of Incidental coronary artery disease
Measured: Visit 4 (Day 365 +/- 14)
Detection rate of Incidental coronary artery disease
Measured: Visit 6 (day 730 +/- 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Mar 2021
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Shum, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164757
- Sponsor's protocol ID
- 20-00212
- Acronym
- FANSS
- Status last verified
- Jun 2026
- First submitted
- 7 Dec 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Asian Nonsmoker Screening Study (FANSS)
- ClinicalTrials.gov ID
- NCT05164757
- Acronym / sponsor ID
- FANSS / 20-00212
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jun 2035 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women of Asian/Asian continent ancestry and ethnic groups are eligible for this trial.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Number of Participants who undergo initial LDCT
Time frame: Visit 2 (Day 30 +/- 7)
9 secondary outcomes
Number of diagnoses of lung cancer
Time frame: Visit 2 (Day 30 +/- 7)
Number of diagnoses of lung cancer
Time frame: Visit 4 (Day 365 +/- 14)
Number of diagnoses of lung cancer
Time frame: Visit 6 (day 730 +/- 14)
Detection rate of Incidental thyroid nodules
Time frame: Visit 2 (Day 30 +/- 7)
Detection rate of Incidental thyroid nodules
Time frame: Visit 4 (Day 365 +/- 14)
Detection rate of Incidental thyroid nodules
Time frame: Visit 6 (day 730 +/- 14)
Detection rate of Incidental coronary artery disease
Time frame: Visit 2 (Day 30 +/- 7)
Detection rate of Incidental coronary artery disease
Time frame: Visit 4 (Day 365 +/- 14)
Detection rate of Incidental coronary artery disease
Time frame: Visit 6 (day 730 +/- 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Shum, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.