Clinical trial NCT05481697: Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin
Official title: Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combined With GRAIL Galleri Testing to Improve Early Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unintended Weight Loss
Keywords: GRAIL Galleri
Unintended Weight Loss
UWL
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: University Hospitals Seidman Cancer Center
First posted: 2022-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Malignant UWL Detection
timeFrame: Up to 3 years post-enrollment
Secondary outcomes:
measure: Non-Malignant UWL Detection
timeFrame: Up to 3 years post-enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Jordan M Winter, MD
role: PRINCIPAL_INVESTIGATOR
References: