A Study of Lung Cancer Screening in People With Unexplained Weight Loss
NCT ID: NCT06717334
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
409 participants
OBSERVATIONAL
2024-12-02
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Puneeth Iyengar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
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
Montefiore Health Systems (Montefiore Medical Center)
The Bronx, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Bernard Park, MD
Role: CONTACT
Facility Contacts
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Puneeth Iyengar, MD, PhD
Role: primary
Puneeth Iyengar, MD, PhD
Role: primary
Puneeth Iyengar, MD, PhD
Role: primary
Puneeth Iyengar, MD, PhD
Role: primary
Puneeth Iyengar, MD, PhD
Role: primary
Puneeth Iyengar, MD, PhD
Role: primary
Neel Chudgar, MD
Role: primary
Puneeth Iyengar, MD, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-302
Identifier Type: -
Identifier Source: org_study_id
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