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NCT Number: NCT06717334

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

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.

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dose CT imaging

Diagnostic Test

at baseline and at Year 1.

Blood draws

Other

at baseline and at Year 1.

Screening questionnaire

Other

at baseline and at 1 year after registration.

Primary outcomes

  1. The incidence of lung cancer in patients with unexplained weight loss

    Time frame: 2 years

    Low Dose CT screening

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard Park, MD

CONTACT

646-888-3346

Puneeth Iyengar, MD, PhD

CONTACT

[email protected]

212-639-5159

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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