Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin
- Conditions
- Unintended Weight Loss
- Interventions
- Diagnostic Test: GRAIL Galleri
- Registration Number
- NCT05481697
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
Unintentional weight loss (UWL) is commonly associated with a wide variety of diseases and there is still no valid diagnostic pathway for evaluating UWL. When detecting UWL coupled with GRAIL Galleri testing, (an investigational pan-cancer early detection test), it is thought that there is a greater positive predictive value in detecting malignancies. This study aims to test the potential synergistic effects of UWL detection and GRAIL usage to detect malignancy at an even earlier rate. UWL will be measured using weekly weight tracking.
- Detailed Description
Enrolled participants will be provided with a Fitbit Aria Smart Scale and will be asked to weigh themselves each week at a similar time of day wearing a similar amount of clothing for a total of three years. These weight data will be automatically pushed to the Fitbit cell phone application and patients who lost ≥5% from their baseline will be identified, and the intentionality of this weight loss (intentional or unintentional) will be assessed. All patients with UWL will be asked to have a GRAIL Galleri test, a health history and physical examination, a blood draw, imaging, routine cancer screenings done if not already completed, and referral to a specialist if a new cancer is detected.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description UWL and GRAIL Galleri Testing GRAIL Galleri Enrolled participants will have an initial blood sample taken and record their weights weekly on a FitBit Aria scale for three years to detect for UWL Those who unintentionally lost lost ≥5% from their baseline weight will be identified and have a GRAIL Galleri blood test, physical examination, imaging, and cancer screenings to test for malignancy
- Primary Outcome Measures
Name Time Method Malignant UWL Detection Up to 3 years post-enrollment High-risk participant cohorts who have lost greater than or equal to 5% of their body weight at initial enrollment over the 3-year weight measuring period will be given a GRAIL Galleri test. If positive, the participant will be given laboratory work, imaging, and a physical examination to diagnose the malignancy.
- Secondary Outcome Measures
Name Time Method Non-Malignant UWL Detection Up to 3 years post-enrollment Participants who have lost greater than or equal to 5% of their body weight at initial enrollment over the 3-year weight measuring period but tested negatively during a GRAIL Galleri test will be seen by a specialist to determine their underlying cause of UWL.
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States