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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Lung Cancer Screening

Treatments: Diagnostic Test: Low Dose CT imaging; Other: blood draws; Other: screening questionnaire

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06717334

24-302

Details and patient eligibility

About

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.

Enrollment: 409 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

409 participants in 1 patient group

Patients undergoing Lung cancer screening

Description:

All patients will undergo prospective LDCT imaging annually. At baseline and Year 1, patients will also undergo biospecimen collection for post-hoc ctDNA analysis.

Treatment:

Other: screening questionnaire

Other: blood draws

Diagnostic Test: Low Dose CT imaging