GRAIL Galleri Test for Early Cancer Detection

Overseen By Elizabeth ODonnell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Invasive malignancy, Active cancer, Hematologic precursor, others

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

Compensation: Varies

Number of Visits: 2

1000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, hormone therapy for breast or prostate cancer is allowed, so you may not need to stop those treatments.

What data supports the effectiveness of the GRAIL Galleri Test treatment for early cancer detection?

The GRAIL Galleri Test is being evaluated in a large trial with 140,000 participants in England, aiming to see if it can reduce the number of late-stage cancer cases. It reportedly detects 50 different cancers and is expected to lower cancer deaths by about 25%, which could significantly impact overall mortality rates. ^{1 2 3 4 5}

Is the GRAIL Galleri Test safe for humans?

The GRAIL Galleri Test is being evaluated in large trials, like the NHS-Galleri trial, which involves over 140,000 participants. While the test aims to detect cancer early, potential harms include false positive and negative results, overdiagnosis, overtreatment, and psychological and economic impacts. These trials are designed to assess the test's safety and effectiveness in reducing late-stage cancer incidence. ^{1 2 3 4 6}

How is the GRAIL Galleri Test different from other cancer detection treatments?

The GRAIL Galleri Test is unique because it is a blood test designed to detect multiple types of cancer early, even before symptoms appear, by identifying cancer signals in cell-free DNA. Unlike traditional cancer screenings that focus on specific cancers, this test can potentially detect up to 50 different cancers with a single blood draw, aiming to reduce late-stage cancer incidence and mortality. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this research study is to evaluate the possible benefits and harms of screening with an investigational blood test designed to detect many types of cancer early. The name of the screening blood test being studied is: -GRAIL Galleri test

Research Team

Elizabeth ODonnell, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals at high risk of developing cancer due to genetic predisposition or a known syndrome that increases cancer risk. Specific eligibility details are not provided, but typically participants would have a family history of cancer or carry genes associated with higher cancer risks.

Inclusion Criteria

Inclusion Criteria Group 2 - Familial Risk:

My genetic test showed I have inherited cancer risk genes.

I am older than 45.

Exclusion Criteria

I had surgery to lower my inherited cancer risk.

Have had a blood-based multi-cancer screening test within last year

I was diagnosed with cancer less than 3 years ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline questionnaires and blood test

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the GRAIL Galleri test, including follow-up assessments and recommended cancer screenings

Up to 3 years

Annual follow-up phone call, additional visits if positive test

Diagnostic Resolution

For participants with a positive GRAIL test, additional diagnostic procedures such as lab tests, imaging, and biopsies are conducted

Up to 24 months

Treatment Details

Interventions

• GRAIL Galleri Test

Trial Overview The study is evaluating the GRAIL Galleri test, an investigational blood test designed to detect multiple types of cancers early in people who may be genetically more likely to develop them.

Participant Groups

Group I: Galleri MCED Test Experimental Treatment 1 Intervention

Participants will be enrolled and will complete: * Baseline questionnaires and blood test. * Post-test questionnaires. * Follow-up assessments for a negative GRAIL Galleri test include recommended cancer screenings and a follow up phone call with study staff 1 year after the GRAIL Galleri blood test. * Follow-up assessments for a positive GRAIL test may include clinic visits, lab tests with additional blood work-ups, biopsies, surgical procedures, or imaging assessments such as ultrasound, Computed Tomography (CT) scans, or an Magnetic Resonance Imaging (MRI) scans. * If cancer status is confirmed, participants will complete a post-diagnostic questionnaire.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

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]

The NHS-Galleri trial is a large-scale randomized controlled trial involving over 140,000 participants aged 50-77, designed to evaluate whether a multi-cancer early detection (MCED) test can reduce the incidence of late-stage cancers (stage III and IV).

Participants in the intervention group will receive urgent investigations only if a cancer signal is detected in their blood, allowing for early treatment while maintaining blinding for those without signals, which helps assess the test's effectiveness in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell-Free DNA-Based Multi-Cancer Early Detection Test in an Asymptomatic Screening Population (NHS-Galleri): Design of a Pragmatic, Prospective Randomised Controlled Trial. Neal, RD., Johnson, P., Clarke, CA., et al.[2022]

New cancer early detection tests, including multi-cancer early detection (MCED) tests, show great promise in improving cancer screening, but they are primarily intended to complement existing tests rather than replace them.

While these tests offer potential benefits, they also carry risks such as false positives and negatives, overdiagnosis, and psychological or economic harms, highlighting the need for careful evaluation in large-scale studies being conducted in the U.S. and U.K. to assess their real-world impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Cancer Early Detection: The New Frontier in Cancer Early Detection. Guerra, CE., Sharma, PV., Castillo, BS.[2023]

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]

The study modeled the residual cancer risk (RR) during the diagnostic process following a positive multi-cancer early detection (MCED) test, showing that even after a negative confirmatory test, the RR can remain significant, ranging from 6% to 20%.

The findings suggest that a second-predicted cancer signal origin (CSO) still provides a notable RR (3%-18%) after a negative confirmatory test, indicating that positive MCED results can significantly influence follow-up decisions in cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeled residual current cancer risk after clinical investigation of a positive multicancer early detection test result. Hudnut, AG., Hubbell, E., Venn, O., et al.[2023]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Cell-Free DNA-Based Multi-Cancer Early Detection Test in an Asymptomatic Screening Population (NHS-Galleri): Design of a Pragmatic, Prospective Randomised Controlled Trial. [2022]

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

Multi-Cancer Early Detection: The New Frontier in Cancer Early Detection. [2023]

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

MCED Testing Enters New Diagnostic Realms. [2023]

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

Modeled residual current cancer risk after clinical investigation of a positive multicancer early detection test result. [2023]