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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the GRAIL Galleri blood test can detect cancer earlier in individuals experiencing unintentional weight loss (losing weight without trying). Participants will track their weight weekly, and if they lose 5% or more from their starting weight, they will receive the blood test and undergo additional checks for any signs of cancer. The study seeks individuals who have unintentionally lost weight and are interested in using this test for early cancer detection. Ideal participants should have access to a compatible device for tracking their weight and should not be currently diagnosed with cancer or actively trying to lose weight. As an unphased trial, this study provides a unique opportunity to contribute to innovative cancer detection research.

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.

What prior data suggests that the GRAIL Galleri test is safe for detecting cancer in cases of unintended weight loss?

Research has shown that the GRAIL Galleri test can detect many types of cancer from a single blood sample. The FDA has not yet approved this test. However, studies have found it rarely gives false alarms, with a low false positive rate of only 0.4%. This means it almost never incorrectly indicates cancer, helping to avoid unnecessary procedures and radiation exposure.

No specific reports of physical harm from the test itself exist. It involves taking a blood sample, which is generally safe and routine. Like any blood test, there might be a small chance of minor bruising or discomfort at the site where the blood is drawn. Overall, evidence suggests the test is well-tolerated with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GRAIL Galleri test is unique because it uses a simple blood test to detect over 50 types of cancer, including those that are hard to find in the early stages, by identifying DNA markers associated with cancer. Researchers are excited about this method because it allows for earlier detection of cancer in patients experiencing unintended weight loss, a common but often overlooked symptom of potential malignancy. Unlike traditional diagnostic options that often require invasive procedures, the Galleri test offers a non-invasive, comprehensive screening that could lead to earlier intervention and treatment, potentially improving patient outcomes significantly.

What evidence suggests that the GRAIL Galleri test is effective for detecting cancer in cases of unintended weight loss?

Research has shown that the GRAIL Galleri test can help detect cancer early. In the PATHFINDER 2 study, the test identified a cancer signal in 216 people, and 133 of them were confirmed to have cancer. This finding suggests the test could be very useful for early detection. In this trial, participants will undergo the GRAIL Galleri test if they experience unintended weight loss, as it can identify more than 50 types of cancer, often at an early stage when treatment is easier. Although some concerns exist about its effectiveness, the test has shown promise in detecting more cancers when used alongside regular screenings. ^{1 5 6 7 8}

Who Is on the Research Team?

Jordan M. Winter, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

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

I am willing and able to follow the study rules and attend all appointments.

I am between 40 and 80 years old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05481697

NCT05481697 | Unintentional Weight Loss and Cancer: A ... 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 ...

2. grail.com grail.com/press-releases/grail-pathfinder-2-results-show-galleri-multi-cancer-early-detection-blood-test-increased-cancer-detection-more-than-seven-fold-when-added-to-uspstf-a-and-b-recommended-screenings/

GRAIL PATHFINDER 2 Results Show Galleri® Multi ... The Galleri test detected a cancer signal in 216 participants (cancer signal detection rate of 0.93%), and of those, cancer was diagnosed in 133 ...

3. withpower.com withpower.com/trial/phase-weight-loss-2023-d7edc

GRAIL Galleri Test for Detecting Cancer in Unintended ... Real-world data and clinical trial results support the effectiveness of a single blood draw for screening multiple cancers, indicating a promising advancement ...

4. bbc.com bbc.com/news/articles/c205g21n1zzo

Galleri test: Exciting results from blood test for 50 cancers More than half the cancers were detected at an early stage, where they are easier to treat and potentially curable. The Galleri test, made by ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11886625/

Implosion of Grail's Galleri Cancer Screening Test? - PMC A recent prospective clinical trial using the Galleri Multi-Cancer Detection Test was temporarily put on hold, likely due to poor clinical performance.

6. grail.com grail.com/press-releases/grail-and-university-of-oxford-present-long-term-data-from-the-symplify-study-evaluating-the-galleri-multi-cancer-early-detection-test-in-symptomatic-individuals-at-the-early-detection-of-cancer/

GRAIL and University of Oxford Present Long-Term Data ... * The Galleri test approximately doubles the number of cancers detected when added to standard of care screening and has the lowest false positive rate of any ...

7. grail.com grail.com/galleri-test/

Galleri® multi-cancer early detection test Galleri has a false positive rate of just 0.4%— the lowest of any available MCED test ** — helping to minimize unnecessary procedures and exposure to radiation.

8. prnewswire.com prnewswire.com/news-releases/grail-and-university-of-oxford-to-present-long-term-data-from-the-symplify-study-evaluating-the-galleri-multi-cancer-early-detection-test-in-symptomatic-individuals-at-the-early-detection-of-cancer-conference-edcc-302588885.html

GRAIL and University of Oxford to Present Long-Term Data ... The Galleri test has not been cleared or approved by the Food and Drug Administration. The GRAIL clinical laboratory is regulated under CLIA to ...