Unintended Weight Loss
Conditions
Keywords
GRAIL Galleri, Unintended Weight Loss, UWL
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.
Interventions
DIAGNOSTIC_TESTGRAIL Galleri
A blood test that aims to detect cancers earlier by looking for abnormal DNA shed from cancer cells into the blood.
Sponsors
Case Comprehensive Cancer Center
University Hospitals Seidman Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTJordan M Winter, MD
PRINCIPAL_INVESTIGATORJordan M Winter, MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Outcome results
None listed