Tracking weight loss to improve cancer detection
Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combined With GRAIL Galleri Testing to Improve Early Detection
This study is testing if tracking weight loss in people aged 40 to 80 can help catch cancer earlier using a new blood test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05481697 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between unintentional weight loss (UWL) and cancer detection using the GRAIL Galleri test, an investigational pan-cancer early detection test. Participants aged 40 to 80 will track their weight weekly using a Fitbit Aria Smart Scale for three years. Those who experience a weight loss of 5% or more will undergo further assessments, including the GRAIL Galleri test, health history evaluations, and necessary imaging or screenings. The goal is to determine if combining UWL detection with GRAIL testing can enhance early cancer detection rates.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 80 who can use a compatible device for weight tracking and are willing to participate in the study.
Not a fit: Patients currently diagnosed with cancer or actively trying to lose weight through medications or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of malignancies in patients experiencing unintentional weight loss.
How similar studies have performed: While the specific combination of UWL tracking and GRAIL testing is novel, similar studies have shown promise in early cancer detection methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age range: from 40 to 80 years * Access to a device (cellphone, computer, tablet) that is compatible with the Fitbit Aria Air smart scale utilized in this study * Willing to comply with all study procedures and be available for the duration of the study * Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document * Subjects must speak English to maximize chance of understanding the trial rational and study procedures Exclusion Criteria: * Active cancer diagnosis - current diagnosis, currently undergoing cancer treatment, or concluded cancer treatments within 3 years * Actively trying to lose weight with medications or bariatric surgery * Pregnant
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jordan M Winter, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Study coordinator: Jordan M Winter, MD
- Email: Jordan.Winter@UHHospitals.org
- Phone: (216) 844-5777
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.