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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2026-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Unintended Weight Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

GRAIL Galleri

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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GRAIL Galleri

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No