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

NCT05481697 | Recruiting DMC

• 1 other identifier: CASE3Y22
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

GRAIL Galleri; Unintended Weight Loss; UWL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Non-Malignant UWL Detection

  Up to 3 years post-enrollment

Study Arms (1)

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

Diagnostic Test: GRAIL Galleri

Interventions

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.

UWL and GRAIL Galleri Testing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• University Hospitals Seidman Cancer Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

Study Officials

• Jordan M Winter, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan M Winter, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)