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Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combined With GRAIL Galleri Testing to Improve Early Detection

Who can join

Ages 40 to 80 · All sexes

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

About the study

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.

What is being tested

• GRAIL Galleri (diagnostic test)

Sponsor: Case Comprehensive Cancer Center · Participants: 1,000 · Started: May 5, 2023

Contact the study team

• Jordan M Winter, MD · Phone: (216) 844-5777

Official record on ClinicalTrials.gov — NCT05481697

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.