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

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

What data supports the effectiveness of the GRAIL Galleri MCED test as a treatment for early cancer detection?

The NHS-Galleri trial is studying the GRAIL Galleri MCED test to see if it can reduce the number of late-stage cancer cases by detecting cancer early in people without symptoms. Early results suggest that if the test can lower the number of advanced cancer cases, it might help reduce cancer deaths. ^{1 2 3 4 5}

Is the GRAIL Galleri MCED test safe for humans?

The GRAIL Galleri MCED test is a blood test designed to detect cancer early, and it is currently being evaluated in large trials like the NHS-Galleri trial. While the test itself involves a simple blood draw, potential risks include false positive or negative results, which could lead to unnecessary stress or additional testing. ^{1 3 4 6 7}

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

The GRAIL Galleri MCED test is unique because it can detect multiple types of cancer from a single blood test, even before symptoms appear, with a low false-positive rate. Unlike traditional screenings that focus on specific cancers, this test can identify a shared cancer signal from any site in the body and predict the cancer's origin, potentially reducing late-stage cancer diagnoses. ^{3 4 5 8 9}

What is the purpose of this trial?

The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty. The name of the screening blood test being studied is: -GRAIL Galleri MCED test

Research Team

Elizabeth ODonnell, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

I am 45 years old or older.

Received care at a VA facility within past 5 years

Able to sign informed consent

Exclusion Criteria

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

I need treatment for my active cancer symptoms, but hormone therapy for breast or prostate cancer is okay.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

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

Multi-Cancer Early Detection Tests: Current Progress and Future Perspectives. [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. England pubmed.ncbi.nlm.nih.gov

Evaluating multi-cancer early detection tests: an argument for the outcome of recurrence-updated stage. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient Preferences for Multi-Cancer Early Detection (MCED) Screening Tests. [2023]

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

Multicancer Early Detection Tests: An Overview of Early Results From Prospective Clinical Studies and Opportunities for Oncologists. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Modelled mortality benefits of multi-cancer early detection screening in England. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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]