GRAIL Galleri Test for Detecting Cancer in Unintended Weight Loss

Overseen By Jordan M Winter, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Active cancer, Weight loss meds, Pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves using a smart scale for regular weight tracking and a special blood test to detect cancer early. It targets people who lose weight without trying, aiming to find cancer sooner by combining weight monitoring with advanced blood testing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are actively trying to lose weight with medications, you would not be eligible to participate.

How is the GRAIL Galleri test different from other treatments for detecting cancer in unintended weight loss?

The GRAIL Galleri test is unique because it uses a single blood draw to screen for multiple types of cancer by detecting circulating tumor DNA (ctDNA), which is different from traditional methods that typically focus on one type of cancer at a time. This test can potentially identify the tissue of origin for cancers, offering a novel approach to early cancer detection. ^{1 2 3 4 5}

Research Team

Jordan M. Winter, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for English-speaking individuals aged 40-80 who have unintentionally lost weight and are willing to track it weekly using a smart scale. They must be mentally competent, able to consent, and have access to a compatible device. It's not for those pregnant, actively trying to lose weight, or with an active/recent cancer diagnosis.

Inclusion Criteria

I am between 40 and 80 years old.

I can understand and am willing to sign the consent form.

Access to a device (cellphone, computer, tablet) that is compatible with the Fitbit Aria Air smart scale utilized in this study

Exclusion Criteria

I am currently diagnosed with cancer, receiving treatment, or finished treatment within the last 3 years.

I am currently trying to lose weight through medication or surgery.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Tracking

Participants record their weights weekly using a Fitbit Aria Smart Scale to detect unintentional weight loss

3 years

Weekly self-monitoring

GRAIL Galleri Testing

Participants with unintentional weight loss undergo GRAIL Galleri blood test, physical examination, imaging, and cancer screenings

Up to 3 years post-enrollment

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• GRAIL Galleri

Trial Overview The study is testing the GRAIL Galleri test alongside regular tracking of unintentional weight loss (UWL) in participants. The goal is to see if combining UWL detection with this early cancer detection test can identify malignancies sooner than usual.

Participant Groups

Group I: UWL and GRAIL Galleri Testing Experimental Treatment 1 Intervention

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

GRAIL Galleri is already approved in United States for the following indications:

Approved in United States as Galleri test for:

• Multi-cancer early detection

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

University Hospitals Seidman Cancer Center

Collaborator

Trials

5

Recruited

1,100+

Findings from Research

The NHS-Galleri trial is assessing a multi-cancer early detection (MCED) test aimed at reducing the incidence of late-stage cancer, which could lead to better patient outcomes through earlier diagnosis and treatment.

However, the authors caution that simply reducing late-stage cancer cases may not directly correlate with lower cancer mortality due to the presence of micro-metastatic disease, suggesting a need for adjustments in how trial outcomes are measured.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating multi-cancer early detection tests: an argument for the outcome of recurrence-updated stage. Callister, MEJ., Crosbie, EJ., Crosbie, PAJ., et al.[2023]

The GRAIL GalleriTM multi-cancer screening test will be evaluated in a large randomized trial involving 140,000 healthy participants aged 50-79, with the aim of assessing its impact on all-cause mortality.

This test is designed to detect 50 different types of cancer and is expected to reduce cancer mortality by about 25%, potentially setting a new standard for multi-cancer screening in the National Health Service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-cause mortality as the primary endpoint for the GRAIL/National Health Service England multi-cancer screening trial. Carr, D., Kent, DM., Welch, HG.[2022]

Real-world data and clinical trial results support the effectiveness of a single blood draw for screening multiple cancers, indicating a promising advancement in early cancer detection.

Concerns remain regarding the performance of GRAIL's multicancer early detection test in high-risk groups that were not included in the initial clinical studies, highlighting the need for further evaluation in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MCED Testing Enters New Diagnostic Realms. [2023]

A blood test developed by Grail can detect early-stage cancers with a detection rate of 55.1% across various types and stages.

The test also accurately identifies the tissue of origin for the detected cancers in 90.2% of cases, showcasing its potential for precise cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Test Detects Early-Stage Cancers. [2020]

The authors express concerns about the efficacy and reliability of circulating tumor DNA (ctDNA) technologies, particularly the Galleri Test developed by GRAIL, for early cancer detection.

They emphasize the importance of constructive scientific debate in addressing these concerns and advancing the field of early cancer detection, highlighting the need for rigorous evaluation of such technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi Cancer Early Detection by Using Circulating Tumor DNA-The Galleri Test. Reply to Klein et al. The Promise of Multicancer Early Detection. Comment on "Pons-Belda et al. Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm. Diagnostics 2021, 11, 2171". Pons-Belda, OD., Fernandez-Uriarte, A., Diamandis, EP.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluating multi-cancer early detection tests: an argument for the outcome of recurrence-updated stage. [2023]

2. England pubmed.ncbi.nlm.nih.gov

All-cause mortality as the primary endpoint for the GRAIL/National Health Service England multi-cancer screening trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

MCED Testing Enters New Diagnostic Realms. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Blood Test Detects Early-Stage Cancers. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Multi Cancer Early Detection by Using Circulating Tumor DNA-The Galleri Test. Reply to Klein et al. The Promise of Multicancer Early Detection. Comment on "Pons-Belda et al. Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm. Diagnostics 2021, 11, 2171". [2022]