NCT07701733

Brief Summary

The researchers are doing this study to learn more about factors that may increase the risk of lung cancer in people who have never smoked. This information may help predict which people who have never smoked may be more likely to get lung cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
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 Progress3%
Jun 2026Jun 2029

Study Start

First participant enrolled

June 30, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2.9 years

First QC Date

July 1, 2026

Last Update Submit

July 16, 2026

Conditions

Lung Cancer

Keywords

26-239

Outcome Measures

Primary Outcomes (1)

  • Identify factors associated with the risk of NSCLC

    analyses will include all participants who completed the demographic and exposure assessment and whole-exome sequencing

    3 years

Study Arms (2)

Case patients

Must have pathologically confirmed primary lung adenocarcinoma.

Other: Questionnaire

Control participants

Must have no personal history of lung cancer, symptoms suspicious for lung cancer, or suspicious pulmonary nodules.

Other: Questionnaire

Interventions

QuestionnaireOTHER

The study questionnaire will be administered at a regular treatment visit for case patients and at a study-specific visit for control participants. At the same visit, 1 vial of blood will be collected for genomic analysis for research purposes from both case patients and control participants. Collection of demographic information and exposure data.

Case patientsControl participants

Eligibility Criteria

Age40 Years - 74 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale at birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Case patients will be recruited from MSK Thoracic Surgery, Medical Oncology, and Radiation Oncology clinics. Case controls, frequency-matched for race (Asian, Black, Others, White) and age (40-49, 50-64, 65-74), will be recruited from among the 20,000 healthy women at average risk for whom screening mammography is performed annually at MSK and among women who present to the MSK Mobile Health Unit or Ralph Lauren Center for screening. The study will also be open to interested community members who meet eligibility criteria, identified through MSK Direct, the MSK Mobile Health Unit, MSK-Medisys partnership and other community outreach, including a community-facing website.

Criteria: * Female at birth * Age 40-74 years * No smoking history * Participants must be never-smokers, defined as having smoked \<100 cigarettes in their lifetime * Documentation of disease - case patients o Case patients must have pathologically confirmed primary lung adenocarcinoma. New and prevalent cases will be eligible. Case patients with a history of prior non-lung cancer will be eligible for the study unless actively being diagnosed or treated for another form of cancer at the time of enrollment. * Criteria for control participants * Control participants must have no personal history of lung cancer, symptoms suspicious for lung cancer, or suspicious pulmonary nodules. Participants recruited as controls and found on imaging to have lesions suspicious for lung cancer will be excluded from analysis and followed prospectively. Data regarding these participants will be reported in a sensitivity analysis. Additional control participants will be recruited to ensure balanced age- and race-matched enrollment by frequency matching. Control participants with a history of prior non-lung cancer will be eligible for the study unless actively being diagnosed or treated for another form of cancer at the time of enrollment.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alexis Chidi, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Chidi, MD, PhD

CONTACT

(929) 829-0677arisestudy@mskcc.org

Tafadzwa Chaunzwa, MD

CONTACT

(929) 829-0677

Study Design

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

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 14, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)