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

Recruiting

• Conditions: Lung Cancer Screening

• Registration Number: NCT06717334
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 detai...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 409

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

• Medical record documentation of weight in an electronic medical record at enrollment and 12 months prior to enrollment, +/- 3 months.

  o Documentation of weight either at the participating institution or at an outside facility are permitted, presuming both weights are documented in an electronic medical record.

• Weight loss of 3-10%, defined as UWL, in the prior 12 months +/- 3 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator

  o Note that patients who have 3-10% weight loss in the past 12 months +/- 3 months and report that it is intentional in nature, may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts.

• Life expectancy greater than 1 year, per assessment of the treating clinician.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of lung cancer in patients with unexplained weight loss	2 years	Low Dose CT screening

Trial Locations

Locations (8)

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

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Montefiore Health Systems (Montefiore Medical Center); 🇺🇸 Bronx, New York, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States