Recruiting

Weight Tracking

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05481697

Conditions

Unintended Weight Loss

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

GRAIL Galleri

Study Details

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.

Conditions

Unintended Weight Loss

Study ID

NCT05481697

Start date

May 5, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: UWL and GRAIL Galleri Testing

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

Interventions

GRAIL Galleri

A blood test that aims to detect cancers earlier by looking for abnormal DNA shed from cancer cells into the blood.

Primary outcome measure

  • Malignant UWL Detection [ Time Frame: Up to 3 years post-enrollment ]

Central Contacts and Locations

Central contacts

Jordan M Winter, MD

(216) 844-5777Jordan.Winter@UHHospitals.org

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Jordan M. Winter, MD

216-844-5777Jordan.Winter@UHHospitals.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • GRAIL Galleri
  • Unintended Weight Loss
  • UWL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-06-12.