Clinical trial NCT06717334: A Study of Lung Cancer Screening in People With Unexplained Weight Loss
Official title: Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Screening
Keywords: ctDNA analysis
Low dose computed tomography (CT)
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2024-12-05
Enrollment: 409
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified at MSKCC largely through survivorship clinics.

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 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.


Eligibility 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

Primary outcomes:
measure: The incidence of lung cancer in patients with unexplained weight loss
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Health Systems (Montefiore Medical Center)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References: