Lung Cancer ScreeningNCT06717334
A Study of Lung Cancer Screening in People With Unexplained Weight Loss
An observational study of Lung Cancer Screening, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Low Dose CT imaging, blood draws and screening questionnaire
- How many people
- 409 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Dec 2024to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential research subjects will be identified at MSKCC largely through survivorship clinics.
Who may be able to join
- Eligible for American Cancer Society lung cancer screening, as follows as per the discretion of the screening team:
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bernard Park, MD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Alexis Chidi, MD, PhD, 212-639-8100
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, 11725
Alexis Chidi, MD, PhD, 212-639-8100
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Alexis Chidi, MD, PhD, 212-639-8100
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Alexis Chidi, MD, PhD, 212-639-8100
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Alexis Chidi, MD, PhD, 212-639-8100
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Alexis Chidi, MD, PhD, 212-639-8100
- Recruiting
Montefiore Health Systems (Montefiore Medical Center)
The Bronx, New York, 10467
Neel Chudgar, MD, 718-920-8874
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Alexis Chidi, MD, PhD, 212-639-8100
About this study
Official title: Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival
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.
- Conditions
- Lung Cancer Screening
- Being tested
- Low Dose CT imaging, blood draws, screening questionnaire
- Keywords
- ctDNA analysis, Low dose computed tomography (CT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose CT imagingDiagnostic test
at baseline and at Year 1.
blood drawsOther
at baseline and at Year 1.
screening questionnaireOther
at baseline and at 1 year after registration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Low Dose CT imaging; Other: blood draws; Other: screening questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of lung cancer in patients with unexplained weight loss
Low Dose CT screening
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start2 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Alexis Chidi, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717334
- Sponsor's protocol ID
- 24-302
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.