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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2029-06-30

Brief Summary

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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).

Detailed Description

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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 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.

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.

Conditions

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Bladder Carcinoma Breast Carcinoma Colorectal Carcinoma Esophageal Carcinoma Gastric Carcinoma Liver Carcinoma Lung Carcinoma Malignant Solid Neoplasm Ovarian Carcinoma Pancreatic Carcinoma Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Four ACCESS Hubs will institute participant blinding to their randomly assigned group. Participants recruited in the remaining ACCESS Hubs will be told the arm to which they have been assigned. The purpose of having some Hubs institute blinding and others unblinded is to assess the impact of blinding on recruitment, participation in standard of care cancer screening, and adherence to the study protocol.

Study Groups

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Arm II (Avantect MCD test)

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 Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood collection

Device Usage

Intervention Type DEVICE

Evaluation of MCD tests

Electronic Health Record Review

Intervention Type OTHER

Obtain health data

Multi-Cancer Detection Test

Intervention Type PROCEDURE

Undergo Avantect MCD test

Questionnaire Administration

Intervention Type OTHER

Study specific questionnaires

Arm III (Control)

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

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood collection

Electronic Health Record Review

Intervention Type OTHER

Obtain health data

Questionnaire Administration

Intervention Type OTHER

Study specific questionnaires

Arm I (Shield MCD test)

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 Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood collection

Device Usage

Intervention Type DEVICE

Evaluation of MCD tests

Electronic Health Record Review

Intervention Type OTHER

Obtain health data

Multi-Cancer Detection Test

Intervention Type PROCEDURE

Undergo Shield MCD test

Questionnaire Administration

Intervention Type OTHER

Study specific questionnaires

Interventions

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Biospecimen Collection

Undergo blood collection

Intervention Type PROCEDURE

Device Usage

Evaluation of MCD tests

Intervention Type DEVICE

Electronic Health Record Review

Obtain health data

Intervention Type OTHER

Multi-Cancer Detection Test

Undergo Shield MCD test

Intervention Type PROCEDURE

Multi-Cancer Detection Test

Undergo Avantect MCD test

Intervention Type PROCEDURE

Questionnaire Administration

Study specific questionnaires

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Usage of Device MCD Assay MCD Test MCED Assay MCED Test Multi Cancer Detection Assay Multi Cancer Detection Test Multi Cancer Early Detection Assay Multi Cancer Early Detection Test Multi-Cancer Detection Assay Multi-Cancer Early Detection Assay Multi-Cancer Early Detection Test MCD Assay MCD Test MCED Assay MCED Test Multi Cancer Detection Assay Multi Cancer Detection Test Multi Cancer Early Detection Assay Multi Cancer Early Detection Test Multi-Cancer Detection Assay Multi-Cancer Early Detection Assay Multi-Cancer Early Detection Test

Eligibility Criteria

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Inclusion Criteria

* Ages 45-75 years old
* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment
* Agree to allow collection of information from their medical records for study-related purposes
* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic

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

Exclusion Criteria

* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years

* Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible
* Ongoing cancer diagnostic work-up
* Ongoing participation in another study of an investigational cancer screening test or technology
* Currently breastfeeding or pregnant, or planning to become pregnant in the next year

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott D Ramsey

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Kaiser Permanente-Division of Research

Pleasanton, California, United States

Site Status RECRUITING

Keefe Memorial Hospital

Cheyenne Wells, Colorado, United States

Site Status RECRUITING

Kaiser Permanente-Franklin

Denver, Colorado, United States

Site Status RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Site Status RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status RECRUITING

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Site Status RECRUITING

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Site Status RECRUITING

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status RECRUITING

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Site Status RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center - Detroit Northwest

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center-Cottage

Grosse Pointe Farms, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center - Livonia

Livonia, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center - Plymouth

Plymouth, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center - Royal Oak

Royal Oak, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center

Sterling Heights, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center - Troy

Troy, Michigan, United States

Site Status RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status RECRUITING

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Sentara Martha Jefferson Hospital

Charlottesville, Virginia, United States

Site Status RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Site Status RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

VCU Community Memorial Health Center

South Hill, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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