NCT05164757

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,041

participants targeted

Target at P75+ for all trials

Timeline
106mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Mar 2021Mar 2035

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2035

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

14 years

First QC Date

December 7, 2021

Last Update Submit

August 14, 2025

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Number of diagnoses of lung cancer

    Visit 2 (Day 30 +/- 7)

  • Number of diagnoses of lung cancer

    Visit 4 (Day 365 +/- 14)

  • Number of diagnoses of lung cancer

    Visit 6 (day 730 +/- 14)

  • Detection rate of Incidental thyroid nodules

    Visit 2 (Day 30 +/- 7)

  • Detection rate of Incidental thyroid nodules

    Visit 4 (Day 365 +/- 14)

  • +4 more secondary outcomes

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women of Asian/Asian continent ancestry and ethnic groups are eligible for this trial.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serial specimens of blood will be collected at the initial screen from each subject. In addition, paraffin blocks from resected lung tumors from any subject who have any pathological specimens from the lung will be collected retrospectively.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Elaine Shum, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 21, 2021

Study Start

March 1, 2021

Primary Completion (Estimated)

March 1, 2035

Study Completion (Estimated)

March 1, 2035

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to FANSS@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)