Recruiting

Lung Cancer Screening

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06717334

Conditions

Lung Cancer Screening

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Low Dose CT imaging

blood draws

screening questionnaire

Study Details

Brief summary:

The researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.

Conditions

Lung Cancer Screening

Study ID

NCT06717334

Start date

Dec 2, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Eligible for American Cancer Society lung cancer screening, as follows as per the discretion of the screening team:

  • Age 50-80 years old
  • At least 20-pack year history of smoking
  • Weight loss of 3-10%, defined as UWL, within any timeframe over the past in the 18 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator

  • Note that patients who have 3-10% weight may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts.
  • Documented weight loss can be self-reported or extracted from weights obtained during physician visits. However, if self-reported weight loss is contradicted by weight loss documented in the medical record (e.g. a patients states that (s)he lost 10 lbs in the past 6 months, but a weight documented in the medical record does not support that history), the measured and quantified weight change will be used to ascertain eligibility
  • Life expectancy greater than 1 year, per assessment of the treating clinician.

Exclusion Criteria:

  • Currently pregnant or trying to become pregnant via self-report
  • Prior history of recent CT scan of the chest either through LDCT screening or with a scan of the chest (standard, not LDCT) performed within the past 12 months
  • Prior history of NSCLC

○ Note that patients with a history of diagnosis of non-lung cancers are eligible for the study.
  • Currently undergoing or referred for diagnostic evaluation due to clinical suspicion for malignancy (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
  • Patients with a germline pathogenic genetic variant who have undergone whole body MRI within the past 12 months
  • Unable to comply with study procedures

Study Design

Enrollment

409 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients undergoing Lung cancer screening

All patients will undergo prospective LDCT imaging annually. At baseline and Year 1, patients will also undergo biospecimen collection for post-hoc ctDNA analysis.

Interventions

Low Dose CT imaging

at baseline and at Year 1.

blood draws

at baseline and at Year 1.

screening questionnaire

at baseline and at 1 year after registration.

Primary outcome measure

  • The incidence of lung cancer in patients with unexplained weight loss [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Amy Xu, MD, PhD

646-888-6863xua@mskcc.org

Bernard Park, MD

646-888-3346

Locations

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

East White Plains, New York, United States, 10604

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Amy Xu, MD, PhD

646-888-6863

Montefiore Health Systems (Montefiore Medical Center)

Recruiting

The Bronx, New York, United States, 10467

Contacts

Neel Chudgar, MD

(718) 920-8874

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Amy Xu, MD, PhD

646-888-6863

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • ctDNA analysis
  • Low dose computed tomography (CT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-04.