A Study of Lung Cancer Screening in People With Unexplained Weight Loss

NCT06717334 | Recruiting

• 1 other identifier: 24-302
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 8

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

Keywords

ctDNA analysis; Low dose computed tomography (CT)

Outcome Measures

Primary Outcomes (1)

• The incidence of lung cancer in patients with unexplained weight loss

  Low Dose CT screening

  2 years

Study Arms (1)

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.

Diagnostic Test: Low Dose CT imaging; Other: blood draws; Other: screening questionnaire

Interventions

Low Dose CT imaging DIAGNOSTIC_TEST

at baseline and at Year 1.

Patients undergoing Lung cancer screening

blood draws OTHER

at baseline and at Year 1.

Patients undergoing Lung cancer screening

screening questionnaire OTHER

at baseline and at 1 year after registration.

Patients undergoing Lung cancer screening

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified at MSKCC largely through survivorship clinics.

You may qualify if:

• Eligible for American Cancer Society lung cancer screening, as follows:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (8)

Memorial Sloan Kettering at 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

Montefiore Health Systems (Montefiore Medical Center)

The Bronx, New York, 10467, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Puneeth Iyengar, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Puneeth Iyengar, MD, PhD

CONTACT

212-639-5159; iyengarp@mskcc.org

Bernard Park, MD

CONTACT

646-888-3346

Study Design

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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 5, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (8)