Early Detection Test for Cancer

Recruiting at 62 trial locations

Overseen By Marc Matrana, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GRAIL, Inc.

Disqualifiers: Cancer suspicion, Recent cancer history, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

35885 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new blood test called the GRAIL MCED test, which aims to detect multiple types of cancer early. GRAIL, a company formed by DNA-sequencing giant Illumina, is developing the GRAIL MCED test to detect multiple cancer types early. It targets people who are already recommended for cancer screening. The test works by looking for cancer-related DNA in the blood, and if found, further tests are done to confirm and locate the cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that adjuvant hormone therapy for cancer is allowed, so you might be able to continue some treatments. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the Multi-Cancer Early Detection Test treatment?

Research suggests that multi-cancer early detection tests can potentially reduce cancer deaths by identifying multiple types of cancer earlier than current single-cancer screening methods. These tests are being evaluated for their accuracy and impact on patient outcomes in large-scale studies. ^{1 2 3 4 5}

Is the Multi-Cancer Early Detection Test safe for humans?

The Multi-Cancer Early Detection Test is generally considered safe, but there are potential risks such as false positive and negative results, which could lead to unnecessary stress or treatment. Large-scale studies are being conducted to better understand these risks and their impact on health outcomes. ^{1 4 6 7 8}

How is the Multi-Cancer Early Detection Test different from other cancer detection methods?

The Multi-Cancer Early Detection Test is unique because it uses a blood test to detect signals from multiple types of cancer at once, unlike current screening methods that focus on individual cancers. This test can identify the cancer's origin with high accuracy and has a low rate of false positives, potentially improving early detection and reducing the need for multiple separate screenings. ^{1 2 7 8 9}

Research Team

Celine Marquez, MD

Principal Investigator

GRAIL, Inc.

Eligibility Criteria

This trial is for individuals at least 50 years old who can consent to participate and are eligible for cancer screening. They shouldn't have had invasive cancer treatment in the last 3 years, except hormone therapy for breast or prostate cancer. Participants must be registered patients at a participating center and not pregnant.

Inclusion Criteria

Previous or current employees or contractors of GRAIL.

Current pregnancy (by self-report of pregnancy status)

I am able to understand and sign the consent form.

Exclusion Criteria

Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality)

Individuals who will not be able to comply with the protocol procedures

Current pregnancy (by self-report of pregnancy status)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

36 months

Diagnostic Procedures

Participants with a 'cancer signal detected' test result undergo diagnostic procedures to determine if they have cancer

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

3 years

Treatment Details

Interventions

• Multi-Cancer Early Detection Test

Trial Overview The GRAIL multi-cancer early detection (MCED) test is being studied to see how safe and effective it is in detecting various cancers early on. If the test detects a potential cancer signal, participants will undergo further diagnostic procedures to confirm if they have cancer.

Participant Groups

Group I: Participants 50 years of age or older Experimental Treatment 1 Intervention

The study will aim to enroll a diverse participant population generally representative of the US population with respect to race, ethnicity, and sex. The target age categories of 60-69 years and 70-79 years will be enriched to increase the number of cancer events that are observed during the study.

Who Is Running the Clinical Trial?

GRAIL, Inc.

Lead Sponsor

Trials

10

Recruited

381,000+

GRAIL, LLC

Lead Sponsor

Trials

9

Recruited

380,000+

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 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

Transforming the landscape of early cancer detection using blood tests-Commentary on current methodologies and future prospects. [2023]

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

Novel multicancer early detection technology-potential value to employers and the workforce. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes associated with cancer screening: a systematic review. [2022]

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

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

5. Mexico pubmed.ncbi.nlm.nih.gov

Evaluation of C-reactive protein, procalcitonin and the PCR/PCT index as indicators of mortality in abdominal sepsis. [2022]

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]

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

Estimating the population health impact of a multi-cancer early detection genomic blood test to complement existing screening in the US and UK. [2023]

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

Multicancer early detection test: Preclinical, translational, and clinical evidence-generation plan and provocative questions. [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]