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

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).

Conditions

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood collection

DEVICE

Device Usage

Evaluation of MCD tests

OTHER

Electronic Health Record Review

Obtain health data

PROCEDURE

Multi-Cancer Detection Test

Undergo Shield MCD test

PROCEDURE

Multi-Cancer Detection Test

Undergo Avantect MCD test

OTHER

Questionnaire Administration

Study specific questionnaires

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Scott D Ramsey · Fred Hutchinson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-16

Primary Completion

2027-12-31

Completion

2029-06-30

FDA Device

Yes

Countries

• United States

Study Locations