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

Primary Purpose

Unintended Weight Loss

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GRAIL Galleri

About this trial

This is an interventional screening trial for Unintended Weight Loss focused on measuring GRAIL Galleri, Unintended Weight Loss, UWL

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UWL and GRAIL Galleri Testing

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05481697

First Posted

July 28, 2022

Last Updated

October 9, 2023

Sponsor

Case Comprehensive Cancer Center

Collaborators

University Hospitals Seidman Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05481697

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2024 (Anticipated)

Primary Completion Date

January 1, 2026 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

Collaborators

University Hospitals Seidman Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unintended Weight Loss

Keywords

GRAIL Galleri, Unintended Weight Loss, UWL

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UWL and GRAIL Galleri Testing

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

GRAIL Galleri

Intervention Description

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

Primary Outcome Measure Information:

Title

Malignant UWL Detection

Description

Time Frame

Up to 3 years post-enrollment

Secondary Outcome Measure Information:

Title

Non-Malignant UWL Detection

Description

Time Frame

Up to 3 years post-enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jordan M Winter, MD

Phone

216-410-7065

Jordan.Winter@UHHospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jordan M Winter, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jordan M. Winter, MD

Phone

216-410-7065

Jordan.Winter@UHHospitals.org

12. IPD Sharing Statement

Learn more about this trial

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

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