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Recruiting NCT06717334

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

— Observational Lung Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low Dose CT imaging, blood draws, screening questionnaire.
Who it may be relevant to
Registry conditions: Lung Cancer Screening. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival

Overview

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.

Interventions

  • Diagnostic test Low Dose CT imaging
    at baseline and at Year 1.
  • Other blood draws
    at baseline and at Year 1.
  • Other screening questionnaire
    at baseline and at 1 year after registration.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 8 centers
  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Montefiore Health Systems (Montefiore Medical Center) — The Bronx
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Identifiers

NCT: NCT06717334 · 24-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗