GRAIL Galleri Test for Detecting Cancer in Unintended Weight Loss

Recruiting in Palo Alto (17 mi)

Overseen by Jordan M. Winter, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Active cancer, Weight loss meds, Pregnant

No Placebo Group

Approved in 1 Jurisdiction

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.

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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

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Cleveland, OH

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center Lead Sponsor

University Hospitals Seidman Cancer Center Collaborator

References

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

Evaluating multi-cancer early detection tests: an argument for the outcome of recurrence-updated stage. [2023] The advent of multi-cancer early detection (MCED) tests has the potential to revolutionise the diagnosis of cancer, improving patient outcomes through early diagnosis and increased use of curative therapies. The ongoing NHS-Galleri trial is evaluating an MCED test developed by GRAIL, and is using as its primary endpoint the absolute incidence of late-stage cancer. Proponents of this outcome argue that if the test reduces the number of patients with advanced, incurable cancer, it can be reasonably assumed to be benefitting patients by reducing cancer mortality. Here, we argue that this assumption may not always hold due to the phenomenon of micro-metastatic disease, and propose an adjustment to the trial outcome so that it may better reflect the expected effect of the test on cancer mortality.

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] A randomized trial of the GRAIL GalleriTM multi-cancer screening test is being planned for the National Health Service in England, and will have 140,000 healthy participants aged 50-79: 70,000 exposed to screening and 70,000 unexposed. The test reportedly detects 50 different cancers and is expected to reduce all-cancer mortality by approximately 25%. Given this effect size-and that cancer deaths constitute a large fraction of all deaths-the trial is sufficiently large to test the effect on all-cause mortality. Because most patients believe cancer screening "saves lives", the GRAIL/National Health Service collaboration could set the evaluation standard for multi-cancer screening.

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

MCED Testing Enters New Diagnostic Realms. [2023] Real-world performance data and trial results in symptomatic individuals continue to validate the promise of screening for multiple cancers with a single blood draw. However, some worry about the performance of GRAIL's commercially available multicancer early detection test in certain high-risk groups that were not the focus of early clinical development efforts.

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

Blood Test Detects Early-Stage Cancers. [2020] A blood test being developed by Grail may not only detect early-stage cancers, but also determine where those cancers originate: In an ongoing study, the methylation-based assay detected 55.1% of cancers across types and stages and correctly identified the tissue of origin in 90.2% of cases.

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] We recently published some concerns with new technologies which are based on circulating tumor DNA (ctDNA) for early cancer detection. Most of our published criticism, including a commentary in this journal, has focused on tests developed by the biotechnology company GRAIL (their commercial product is also known as The Galleri Test). Scientists from GRAIL provided explanations and rebuttals to our criticism. They also posed some questions. Here, we reiterate our position and provide rebuttals, explanations and answers to these questions. We believe that constructive scientific debates, like this one, can profoundly contribute to advancements in scientific fields such as early cancer detection.