Multi-Cancer Detection Test for Cancer

Recruiting at 34 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Cancer diagnosis, Cancer work-up, Other study, Pregnant, others

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

Compensation: Varies

Number of Visits: 3

24000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests blood-based multi-cancer detection (MCD) tests to evaluate their effectiveness in screening for various cancers before symptoms appear. Participants will join one of three groups: two groups will receive different MCD tests, and one will serve as a control group. The study aims to determine the effectiveness of these tests in early cancer detection and their impact on decisions regarding further care. Individuals aged 45-75, without a cancer diagnosis in the last five years, and who can provide blood samples may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in early cancer detection.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study demonstrated that the Avantect Multi-Cancer Detection Test is a simple blood test designed to screen healthy individuals for cancer. It has been certified in the UK, indicating its safety and reliability. Research on the Shield Multi-Cancer Detection Test shows it is highly accurate in detecting cancer, with a 98.6% specificity rate, meaning it effectively identifies individuals without cancer. Both tests require a blood sample, a common and low-risk procedure.

As these tests are part of a study without a specific phase, safety is likely still under close monitoring. However, the Shield test has received FDA Breakthrough Device Designation, suggesting it showed promise in effectiveness and safety in earlier evaluations. Overall, these tests are non-invasive, generally easy to tolerate, and have few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these multi-cancer detection tests because they offer a revolutionary approach to early cancer detection. Traditional cancer screening methods often focus on specific cancers and may require invasive procedures, but the Avantect and Shield MCD tests use a simple blood draw to screen for multiple cancers at once. This non-invasive technique could potentially catch cancer earlier than conventional methods, which generally target single types of cancer and often involve more complex procedures. By providing the possibility of early detection across various cancer types, these tests have the potential to significantly improve outcomes for patients and reduce the need for more invasive diagnostic methods.

What evidence suggests that this trial's multi-cancer detection tests could be effective for cancer screening?

In this trial, participants will join different arms to evaluate the effectiveness of two Multi-Cancer Detection (MCD) tests. Research has shown that the Avantect MCD test can detect several types of cancer by identifying specific markers in the blood, aiding in early cancer detection when treatment is most effective. Participants in one arm will undergo the Avantect MCD test. Meanwhile, the Shield MCD test, administered to participants in another arm, demonstrated a 98.5% accuracy in identifying individuals without cancer and a 60% success rate in detecting existing cancers. For the six most aggressive cancers, Shield's success rate increases to 74%. Both tests aim to detect cancer early, potentially leading to better treatment outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Scott D Ramsey

Principal Investigator

Fred Hutchinson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 45-75 who can consent and complete questionnaires in English, Spanish, or Arabic. Participants must agree to give blood samples for MCD testing at the start and one year later, and allow access to their medical records.

Inclusion Criteria

I agree to share my medical records for the study.

I understand that my eligibility may depend on Spanish or Arabic language requirements.

I agree to give blood samples when I join the study and again after 1 year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Testing

Participants undergo blood collection for MCD testing at enrollment

1 week

1 visit (in-person)

Intervention

Participants undergo MCD testing and receive results; follow-up with clinicians for abnormal results

1 year

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Multi-Cancer Detection Test

Trial Overview

The study tests a new Multi-Cancer Detection (MCD) test that screens multiple cancers using blood markers. Adults without cancer are randomly placed into two MCD test groups or a control group to compare effectiveness in early cancer detection.

How Is the Trial Designed?

Group I: Arm II (Avantect MCD test) Experimental Treatment 5 Interventions

Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.

Group II: Arm I (Shield MCD test) Experimental Treatment 5 Interventions

Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.

Group III: Arm III (Control) Active Control 3 Interventions

Participants undergo blood collection at enrollment and after one year on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1.

fredhutch.org

fredhutch.org/en/news/releases/2025/07/vanguard-study-launch.html

Fred Hutch leads new Vanguard Study for Cancer ...

Each MCD test screens for several kinds of cancer, and the MCD tests in the Vanguard study will screen for the following cancers: bladder, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06995898

The Vanguard Study: Testing a New Way to Screen for ...

An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously.

3.

clearnotehealth.com

clearnotehealth.com/press-release/clearnote-healths-avantect-multi-cancer-detection-test-selected-for-national-cancer-institutes-vanguard-study/

ClearNote Health's Avantect® Multi-Cancer Detection Test ...

The Avantect Multi-Cancer Detection Test was one of two tests selected after a thorough evaluation of emerging multi-cancer detection technologies.

4.

cancer.gov

cancer.gov/clinicaltrials/NCI-2024-10793

The Vanguard Study: Testing a New Way to Screen for ...

This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and ...

5.

unclineberger.org

unclineberger.org/news/unc-lineberger-launches-study-to-evaluate-multi-cancer-detection-tests/

UNC Lineberger launches study to evaluate multi-cancer ...

MCD tests detect biological substances released in the bloodstream by cancer cells. Each MCD test screens for several kinds of cancer, and the ...

6.

prevention.cancer.gov

prevention.cancer.gov/clinical-trials/clinical-trials-search/nct06995898

A Study to Evaluate Multicancer Detection (MCD) Tests and ...

The Avantect MCD test reports on the possible presence of 8 cancers: breast, colorectal, esophagus, stomach, liver, lung, ovarian and pancreas and may indicate ...

7.

fredhutch.org

fredhutch.org/en/news/center-news/2025/09/are-we-ready-for-multi-cancer-detection-tests.html

Are we ready for multi-cancer detection tests?

Instead of imaging tests (like a mammogram or low-dose CT lung scan), MCDs measure bits of tumor DNA that cancer cells shed, mostly in the blood ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06995898

The Vanguard Study: Testing a New Way to Screen for ...

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized ...

9.

onclive.com

onclive.com/view/avantect-multi-cancer-and-ovarian-cancer-detection-tests-achieve-ukca-marking

Avantect Multi-Cancer and Ovarian Cancer Detection Tests ...

The Avantect multi-cancer detection test and Avantect ovarian cancer test have received a marking from the United Kingdom Conformity ...