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

Last updated: August 9, 2025
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Pancreatic Cancer

Esophageal Disorders

Treatment

Electronic Health Record Review

Questionnaire Administration

Multi-Cancer Detection Test

Clinical Study ID

NCT06995898
NCI-2024-10793
UG1CA286954
NCI-2024-10793
CSRN1
P30CA015704
  • Ages 45-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. 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 their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 45-75 years old

  • Agree to provide blood samples for possible MCD testing at enrollment and at 1 yearfollowing enrollment

  • Agree to allow collection of information from their medical records forstudy-related purposes

  • Understand and be able to complete informed consent and participant questionnairesin English, Spanish, or Arabic

  • Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion

Exclusion

Exclusion Criteria:

  • Solid malignant tumor or blood cancer diagnosis, with or without treatment, withinthe last 5 years

  • Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situof the breast, cervical cancer in situ, atypical melanocytic hyperplasia ormelanoma in situ) or nonmelanoma skin cancer are eligible

  • Ongoing cancer diagnostic work-up

  • Ongoing participation in another study of an investigational cancer screening testor technology

  • Currently breastfeeding or pregnant, or planning to become pregnant in the next year

Study Design

Total Participants: 24000
Treatment Group(s): 5
Primary Treatment: Electronic Health Record Review
Phase:
Study Start date:
June 16, 2025
Estimated Completion Date:
June 30, 2029

Study Description

PRIMARY OBJECTIVES:

I. Assess the feasibility of recruitment and adherence to protocol-required baseline and follow-up data and blood collection.

II. Assess the feasibility of achieving representative enrollment across participating recruitment sites.

SECONDARY OBJECTIVES:

I. To assess the impact of participant blinding on willingness to participate, adherence to protocol required baseline and follow-up data, blood collection, and on rates of standard of care screening.

II. To determine the timeliness of returning test results to participants. III. To understand the factors contributing to lack of diagnostic resolution of an abnormal MCD test.

IV. To examine the effects of participant characteristics, including cancer risk factors and social determinants of health, on all aspects of feasibility.

V. To estimate the proportion of participants receiving an MCD test outside of the trial.

VI. To assess the feasibility of a staggered introduction of the second MCD assay intervention arm.

VII. To estimate the proportion of abnormal MCD tests that are diagnostically resolved, and the time to resolution.

VIII. To compare the proportion of participants who receive standard of care screening during follow-up between the intervention and control arms.

IX. To assess the accuracy of tissue of origin prediction for each MCD assay. X. To estimate the incidence of complications related to diagnostic evaluation of an abnormal MCD test result.

XI. To assess the effect of an abnormal MCD test and diagnostic workup on anxiety and cancer worry.

XII. To evaluate the clinical diagnostic performance of the MCD assays.

EXPLORATORY OBJECTIVES:

I. To estimate rates of late-stage cancer, and the distribution of cancer stage.

II. To estimate assay-targeted cancer-specific mortality of each MCD assay, all cancer-specific mortality, and all-cause mortality.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: 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.

ARM II: 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. (This arm is not yet open)

ARM III (Control): Participants undergo blood collection at enrollment and after one year on study.

After completion of study intervention, participants are followed passively up to 10 years.

Connect with a study center

  • Inova Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

    12.39 miles

  • Sentara Martha Jefferson Hospital

    Charlottesville, Virginia 22911
    United States

    Active - Recruiting

    93.85 miles

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

    101.44 miles

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

    101.44 miles

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia 23235
    United States

    Active - Recruiting

    104.9 miles

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

    152.87 miles

  • VCU Community Memorial Health Center

    South Hill, Virginia 23970
    United States

    Active - Recruiting

    165.66 miles

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

    1,145.88 miles

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.