Enrichment of Lung Cancer Screening Through Unexplained Weight Loss (UWL) to Stage Shift and Improve Survival

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Diagnostic test, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Montefiore Health Systems (Montefiore Medical Center)
NOT_YET_RECRUITING
The Bronx
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Daniel Gomez, MD
gomezd@mskcc.org
212-639-2087
Backup
Bernard Park, MD
646-888-3346
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 409
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov