Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combined With GRAIL Galleri Testing to Improve Early Detection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GRAIL Galleri.
- Who it may be relevant to
- Registry conditions: Unintended Weight Loss. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test GRAIL Galleri
A blood test that aims to detect cancers earlier by looking for abnormal DNA shed from cancer cells into the blood.
Primary outcome measures
- Malignant UWL Detection [Time frame: Up to 3 years post-enrollment]
Secondary outcome measures (1)
- Non-Malignant UWL Detection [Time frame: Up to 3 years post-enrollment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland
Identifiers
NCT: NCT05481697 · CASE3Y22