Trials / Recruiting

RecruitingNCT06995898

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 24,000 (estimated)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 45 Years – 75 Years
Healthy volunteers: Accepted

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).

Detailed 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 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

Interventions

Type	Name	Description
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

Timeline

Start date: 2025-06-16
Primary completion: 2027-12-31
Completion: 2029-06-30
First posted: 2025-05-30
Last updated: 2026-04-13

Locations

36 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06995898. Inclusion in this directory is not an endorsement.