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NCT Number: NCT05481697

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Jordan M. Winter, MD

CONTACT

[email protected]

216-844-5777

About this study

Enrolled participants will be provided with a Fitbit Aria Smart Scale and will be asked to weigh themselves each week at a similar time of day wearing a similar amount of clothing for a total of three years. These weight data will be automatically pushed to the Fitbit cell phone application and patients who lost ≥5% from their baseline will be identified, and the intentionality of this weight loss (intentional or unintentional) will be assessed. All patients with UWL will be asked to have a GRAIL Galleri test, a health history and physical examination, a blood draw, imaging, routine cancer screenings done if not already completed, and referral to a specialist if a new cancer is detected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Malignant UWL Detection

    Time frame: Up to 3 years post-enrollment

    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.

Secondary outcomes

  1. Non-Malignant UWL Detection

    Time frame: Up to 3 years post-enrollment

    Participants who have lost greater than or equal to 5% of their body weight at initial enrollment over the 3-year weight measuring period but tested negatively during a GRAIL Galleri test will be seen by a specialist to determine their underlying cause of UWL.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan M Winter, MD

CONTACT

[email protected]

(216) 844-5777

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • University Hospitals Seidman Cancer Center

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.