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| Name | Class |
|---|---|
| University Hospitals Seidman Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UWL and GRAIL Galleri Testing | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRAIL Galleri | Diagnostic Test | A blood test that aims to detect cancers earlier by looking for abnormal DNA shed from cancer cells into the blood. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Malignant UWL Detection | 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. | Up to 3 years post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Malignant UWL Detection | 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. | Up to 3 years post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan M Winter, MD | Contact | (216) 844-5777 | Jordan.Winter@UHHospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Jordan M Winter, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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