Early Detection Test for Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new tool, the multi-cancer early detection (MCED) test, to determine if it can safely and effectively detect cancer early in individuals eligible for standard cancer screenings. If the test detects signs of cancer, participants will undergo further checks to confirm a diagnosis. The trial also seeks to understand participants' feelings about using this test. Individuals who are at least 50 years old and can provide informed consent may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in cancer detection.

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 prior data suggests that this test is safe for early cancer detection?

Research has shown that multi-cancer early detection (MCED) tests, such as the GRAIL Galleri test, are designed to detect multiple types of cancer using a single blood sample. This is particularly useful for identifying cancers without regular screening tests. MCED tests function by detecting DNA from cancer cells in the blood.

Although specific safety data from these sources is not available, the trial is in a "not applicable" phase, focusing on evaluating the test's effectiveness rather than early safety reports. Blood tests are generally considered low-risk, as they involve only a blood sample. Existing research has not reported major safety issues with similar MCED tests, suggesting the test is likely well-tolerated. However, as with any medical test, there may be a small risk of side effects, such as bruising from the blood draw. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multi-Cancer Early Detection Test because it offers a novel approach to spotting cancer early, potentially before symptoms appear. Unlike traditional methods that typically focus on detecting a single type of cancer through specific screenings, this test aims to identify multiple cancers using a single blood draw. This could lead to earlier interventions and better outcomes for patients, especially those in higher age brackets where the likelihood of cancer increases. By targeting a broad range of cancers with one test, it represents a significant shift towards more comprehensive and non-invasive cancer detection.

What evidence suggests that the Multi-Cancer Early Detection Test is effective for early cancer detection?

Research shows that multi-cancer early detection (MCED) tests, like the one studied in this trial, can identify several types of cancer from a single blood sample. Studies have found that detecting cancer early with these tests may lead to better treatment outcomes, as they can identify cancer before symptoms appear. The tests have a low rate of false positives, accurately identifying cancer with few errors. Early detection often allows treatment to begin sooner, potentially improving survival rates and outcomes for patients. Overall, evidence suggests that MCED tests could offer a promising way to detect cancer earlier than traditional methods. ^{2 3 4 6 7}

Who Is on the Research Team?

Celine Marquez, MD

Principal Investigator

GRAIL, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11785667/

the potential of multi-cancer early detection (MCED ... Early detection of these cancers through MCED tests can improve treatment outcomes, as symptoms often appear only in advanced stages. Thus, ...

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

Multi-cancer Detection Tests | MCD | GRAIL Galleri Test 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 ...

3. nature.com nature.com/articles/d41586-025-00530-4

Putting early cancer detection to the test And indeed, both Pathfinder and DETECT-A achieved an overall false-positive rate of roughly 1% across the entire cohort that underwent testing — ...

4. friendsofcancerresearch.org friendsofcancerresearch.org/publication/multi-cancer-early-detection-screening-tests-considerations-for-use-of-real-world-data/

Multi-Cancer Early Detection Screening Tests To demonstrate that MCED screening tests improve clinical outcomes, evidence must show the test detects cancers that are otherwise undetected before symptoms ...

5. mdanderson.org mdanderson.org/cancerwise/what-are-multi-cancer-early-detection--mced--tests--and-should-you-get-one.h00-159779601.html

What are multi-cancer early detection (MCED) tests, and ... Early diagnosis enables timely treatment, which may lead to improved survival rates and better patient outcomes. These tests could also allow ...

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

Multi-cancer early detection A blood-based multi-cancer early detection test can help screen for many of the deadliest cancers that don't have recommended screening today.

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35823

Multicancer early detection testing: Guidance for primary care ... MCED tests can detect cancer signals from multiple cancers concurrently in biological samples such as blood, urine, saliva, or other bodily ...