Lung cancer screening for people with unexplained weight loss
Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival
This study is testing if people who have lost weight for no clear reason are more likely to have lung cancer and will use special scans and blood tests to find out.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 409 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT06717334 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate whether individuals experiencing unexplained weight loss are at a higher risk of having or developing lung cancer compared to those without such weight loss. Participants will undergo lung cancer screening using low-dose computed tomography (LDCT), which provides detailed images of the lungs with minimal radiation exposure. Additionally, blood samples will be collected to explore the potential of blood testing in diagnosing lung cancer. The study will include a screening questionnaire to gather relevant health information.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-80 with a significant smoking history and unexplained weight loss of 3-10% over the past 18 months.
Not a fit: Patients whose weight loss can be attributed to an underlying medical condition or intentional efforts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of lung cancer in at-risk populations.
How similar studies have performed: Other studies have shown promise in using low-dose CT for lung cancer screening, but the specific focus on unexplained weight loss is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Montefiore Health Systems (Montefiore Medical Center) — The Bronx, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Puneeth Iyengar, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Puneeth Iyengar, MD, PhD
- Email: iyengarp@mskcc.org
- Phone: 212-639-5159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.