Early Detection Blood Test for Cancer

Overseen By Elizabeth ODonnell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Recent cancer, Active cancer, Cancer evaluation

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

Compensation: Varies

Number of Visits: 3

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the GRAIL Galleri MCED test detects cancer early in veterans who have served in active duty. Participants will provide a blood sample, answer questions, and receive their test results. If the test indicates possible cancer, further tests like imaging or biopsies may be necessary. Veterans who have served for at least eight years and recently received care at a VA facility are ideal candidates. Participants should also be willing to travel to Boston, MA, if follow-up testing is required. As an unphased trial, this study offers veterans the chance to contribute to groundbreaking research in early cancer detection.

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, it does allow hormone therapy for breast or prostate cancer.

What prior data suggests that the GRAIL Galleri MCED test is safe?

Research shows that the Galleri multi-cancer early detection (MCED) test is designed to find signs of cancer in the blood by detecting small pieces of DNA released by cancer cells. This test is often recommended for adults at higher risk for cancer, such as those over 50 years old.

Important safety information indicates that the test is generally safe and well-tolerated. Since it only involves a blood draw, no major side effects have been reported. However, like any blood test, minor discomfort or bruising may occur where the blood is taken.

The test has been widely used in research and commercial settings, which adds to confidence in its safety. While it may not detect all cancers, the test aims to find more types of cancer early, potentially leading to earlier treatment.

Overall, studies have shown that the Galleri test is well-tolerated, supporting its use in ongoing research and for individuals seeking early cancer detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GRAIL Galleri MCED test because it offers a groundbreaking approach to early cancer detection. Unlike traditional methods that typically focus on screening one type of cancer at a time, this blood test can potentially detect more than 50 types of cancer from a single blood draw. This comprehensive testing method not only simplifies the detection process but also aims to identify cancers at an earlier, more treatable stage. By spotting cancer early, the test could lead to better outcomes and less invasive treatments for patients, making it a significant advancement over current screening techniques.

What evidence suggests that the Galleri MCED test is effective for early cancer detection in veterans?

Research shows that the GRAIL Galleri MCED test, which participants in this trial will receive, can help detect cancer early. One study found a cancer signal in about 0.93% of participants, with 133 confirmed cases of cancer. This suggests that the test can identify cancer at an early stage, potentially doubling the number of cancers found when used alongside regular screening methods. The test's overall accuracy in correctly identifying people with cancer is about 51.5% across various types and stages. Thus, the Galleri test could catch many cancers earlier than traditional methods might. ^{4 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 veterans who have served in active military duty and are interested in early cancer detection. Specific eligibility criteria are not provided, but typically participants would need to be at a higher risk of developing cancer.

Inclusion Criteria

Received care at a VA facility within past 5 years

Able to sign informed consent

I am 45 years old or older.

Exclusion Criteria

I was diagnosed with cancer other than non-melanoma skin cancer in the last 3 years.

I have a blood condition like CHIP or MGUS that could affect cancer test results.

Individuals in the process of being evaluated for a clinical suspicion of cancer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline visit with blood draw and questionnaires

1 day

1 visit (in-person)

Testing and Diagnostic Work-up

Participants receive the Galleri MCED test and follow-up diagnostic work-up if positive

Up to 12 months

Multiple visits (in-person and virtual as needed)

Follow-up

Participants are monitored for safety and effectiveness after testing, including repeat tests or surveys

Up to 12 months

Survey or phone call approximately 1 year after initial test

What Are the Treatments Tested in This Trial?

Interventions

• GRAIL Galleri MCED test

Trial Overview

The study is testing the GRAIL Galleri multi-cancer early detection (MCED) blood test, which aims to identify various types of cancers before symptoms appear by analyzing DNA in the participant's blood.

How Is the Trial Designed?

Group I: Galleri MCED Test Experimental Treatment 1 Intervention

Enrolled participants will complete: * Baseline visit with blood draw and questionnaires * Return of study test result * Online post-test questionnaire * For a positive result, diagnostic work-up could include clinic visits, biopsy, surgery, imaging assessments such as ultrasound, Computed Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. If no cancer is found upon work up, a repeat MCED test may be ordered at the discretion of the principle investigator for up to 1 year from the initial MCED blood test. * Follow-up for a negative MCED blood test could include a repeat test ordered by the principle investigator for up to 1 year from the initial MCED test or a survey or phone call by study staff approximately 1 year after the initial MCED blood test. * Online post-diagnostic questionnaire.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

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 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]

Citations

1.

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 ...

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.

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.

4.

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 ...

5.

galleri.com

galleri.com/hcp/galleri-test-performance

Galleri Test Sensitivity & Specificity | Galleri® for HCPs

The overall sensitivity for cancer detection is 51.5% for all cancer types and across all stages.2 This provides the opportunity to detect many additional ...

6.

grail.com

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

Multi-cancer early detection

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and ...

7.

galleri.com

galleri.com/

Blood Test for Cancer Screening | Galleri®

The Galleri® multi-cancer early detection test identifies DNA in the bloodstream shed by cancer cells2 and does not predict future genetic risk for cancer.

8.

galleri.com

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

MCED Test | Early Detection of Cancer with a Signal

Important Safety Information​​ The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does ...

9.

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 ...