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

ConditionUnintended Weight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorCase Comprehensive Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: UWL and GRAIL Galleri TestingExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 3 years post-enrollment

Secondary outcomes

1

Non-Malignant UWL Detection

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.

Time frame
Up to 3 years post-enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Comprehensive Cancer Center

Lead sponsor

University Hospitals Seidman Cancer Center

Collaborator

Source ClinicalTrials.gov
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