Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Unintended Weight Loss

Treatments: Diagnostic Test: GRAIL Galleri

Study type: Interventional

Funder types: Other

Identifiers

NCT05481697

CASE3Y22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

UWL and GRAIL Galleri Testing

Experimental group

Description:

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

Treatment:

Diagnostic Test: GRAIL Galleri