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

Conditions

• Unintended Weight Loss

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

May 5, 2023

Status verified

Feb 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

1,000 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

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

Primary Outcome Measure

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

Central Contacts

• Jordan M Winter, MD
  (216) 844-5777
  [email protected]

Locations (1)

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