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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new blood test called the GRAIL Galleri Test, which aims to detect various cancers early. Researchers seek to determine if this test can identify cancer before symptoms arise, potentially improving treatment outcomes. Participants may be suitable if they have a family history of early-onset cancer or certain genetic conditions that elevate their cancer risk. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to earlier cancer detection and improved treatment options.

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 prior data suggests that the GRAIL Galleri Test is safe for early cancer detection?

Research shows that the Galleri test is designed to detect over 50 types of cancer with a simple blood test. In studies, it identified cancer signals in a small number of participants. For example, in one study, 216 people had a cancer signal, and 133 of them were later confirmed to have cancer. This indicates that the test can successfully detect cancer, but it is not perfect. It may sometimes give false positives (indicating cancer when there isn't any) or false negatives (missing cancer when it is present).

Regarding safety, the test involves just a blood draw, a common and generally safe procedure. No reports of serious side effects have been directly linked to the test. However, if the test shows a positive result, follow-up tests like scans or biopsies might be needed, and these have their own risks. Most people tolerate the initial blood test well. Since this trial doesn't have a specific phase, it focuses on evaluating the test's usefulness rather than its safety, which has been deemed acceptable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GRAIL Galleri Test because it offers a unique approach to early cancer detection by using a simple blood test. Unlike traditional methods that often rely on imaging or invasive procedures to detect cancer, this test analyzes DNA in the blood to identify multiple types of cancer before symptoms appear. This could potentially lead to earlier diagnosis and treatment, improving outcomes for patients. The ability to detect various cancers with one test is a significant advancement, making it a promising tool in the fight against cancer.

What evidence suggests that the GRAIL Galleri test is effective for early cancer detection?

Research has shown that the GRAIL Galleri test, which participants in this trial will undergo, can detect many types of cancer early. In one study, people who received a positive result had about a 62% chance of actually having cancer. Another study found that using the Galleri test alongside regular cancer screenings identified more cancers than standard screenings alone. Real-world data revealed that out of 459 people with a detected cancer signal, 258 actually had invasive cancer. The test has shown promise in identifying cancer signals in many individuals, some of whom did have cancer. Early cancer detection can be crucial for starting treatment sooner. ^{1 6 7 8 9}

Who Is on the Research Team?

Elizabeth ODonnell, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

Citations

1. grail.com grail.com/galleri-test/

Galleri® multi-cancer early detection test People who receive a Cancer Signal Detected test result with Galleri have a high likelihood of having cancer (positive predictive value of approximately 62%). ...

2. grail.com grail.com/press-releases/grail-announces-positive-top-line-results-from-the-galleri%E2%93%A1-pathfinder-2-registrational-study/

GRAIL Announces Positive Top-Line Results From The ... In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER.

3. nature.com nature.com/articles/s41467-025-64094-7

Real-world data and clinical experience from over ... Providers reported clinical outcome for 459 of 1011 individuals with cancer signal detected MCED tests. Of these, 258 had an invasive cancer ...

4. usatoday.com usatoday.com/story/life/health-wellness/2025/11/05/galleri-early-cancer-detection-blood-test/87009742007/

Galleri early cancer detection blood test: I tried it. Galleri discovered cancer signals in 216 people, and 133 of them indeed had cancer.

5. cancer.org cancer.org/cancer/screening/multi-cancer-early-detection-tests.html

Multi-cancer Detection (MCD) Tests Multi-cancer detection (MCD) tests like the GRAIL Galleri test have the potential to find more than one type of cancer from a single sample ...

6. 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 ...

7. galleri.com galleri.com/hcp/the-galleri-test-2

Unlock the potential of multi-cancer early detection The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. False positive and false negative results do occur. ...

8. grail.com grail.com/multi-cancer-early-detection/

Multi-cancer early detection * Galleri can detect 50+ cancer types, with high sensitivity for many of the deadliest cancers in early stages**, and it predicts the Cancer Signal Origin (CSO) ...

9. 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 increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and ...