RecruitingNot ApplicableNCT05481697

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

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

1,000 participants

Start Date

May 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

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Interventions

DIAGNOSTIC_TESTGRAIL Galleri

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


Locations(1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05481697