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Trial Title:
Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin
NCT ID:
NCT05481697
Condition:
Unintended Weight Loss
Conditions: Official terms:
Body Weight
Weight Loss
Conditions: Keywords:
GRAIL Galleri
Unintended Weight Loss
UWL
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
GRAIL Galleri
Description:
A blood test that aims to detect cancers earlier by looking for abnormal DNA shed from
cancer cells into the blood.
Arm group label:
UWL and GRAIL Galleri Testing
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.
Criteria for 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
Gender:
All
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordan M. Winter, MD
Phone:
216-844-5777
Email:
Jordan.Winter@UHHospitals.org
Start date:
October 1, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
University Hospitals Seidman Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05481697
