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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

45 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood collection
• Device Usage — DEVICE
  Evaluation of MCD tests
• Electronic Health Record Review — OTHER
  Obtain health data
• Multi-Cancer Detection Test — PROCEDURE
  Undergo Shield MCD test
• Multi-Cancer Detection Test — PROCEDURE
  Undergo Avantect MCD test
• Questionnaire Administration — OTHER
  Study specific questionnaires

Study Details

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).

Key Dates

Start date

Jun 18, 2025

Status verified

Jun 2026

Primary completion

Jan 31, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

24,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: 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.
• Experimental: 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.
• Active Comparator: Arm III (Control)
  Participants undergo blood collection at enrollment and after one year on study.

Primary Outcome Measure

Feasibility of enrollment onto study [ Time Frame: At time of randomization ]

Locations (37)

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