The Vanguard Study: Testing a New Way to Screen for Cancer
4 other identifiers
interventional
24,000
1 country
37
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedStudy Start
First participant enrolled
June 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
June 11, 2026
June 1, 2026
3.6 years
May 29, 2025
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Feasibility of enrollment onto study
The number of participants enrolled into the study compared to trial goals.
At time of randomization
Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt
The proportion of participants who are complete questionnaires and timing of completion.
Up to 3 years
Proportion of participants who provide the required blood sample for year 1 for Multi-Cancer Detection (MCD) testing within 90 days of recommended time point
The proportion of participants who have a second blood draw and the timing of the blood draw.
Up to 2 years
Proportion of participants considered lost to follow-up within 2 years of randomization
The proportion of participants who do not complete study procedures and are not able to be contacted.
Up to 2 years
Representative enrollment
Meeting or exceeding the trial enrollment goals on a population basis.
Up to 2 years
Staggered start of intervention arm 2
Advantages and challenges arising from trial activation with one intervention arm and later addition of a second intervention arm.
Up to 1 year
Secondary Outcomes (20)
Impact of participant blinding
Up to 2 years
Timely return of MCD test result
Up to 2 years
Factors contributing to lack of diagnostic resolution of an abnormal MCD test
Up to 2 years
Contamination
Up to 3 years
Effects of participant characteristics
Up to 2 years
- +15 more secondary outcomes
Other Outcomes (9)
Cancer stage
Up to 12 years
Early and late stages cancer diagnosis
Up to 12 years
Targeted cancer-specific mortality of each MCD assay
Up to 12 years
- +6 more other outcomes
Study Arms (3)
Arm I (Shield MCD test)
EXPERIMENTALParticipants 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 (Avantect MCD test)
EXPERIMENTALParticipants 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)
ACTIVE COMPARATORParticipants undergo blood collection at enrollment and after one year on study.
Interventions
Evaluation of MCD tests
Undergo blood collection
Obtain health data
Study specific questionnaires
Undergo Shield MCD test
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Kaiser Permanente-Division of Research
Pleasanton, California, 94588, United States
Keefe Memorial Hospital
Cheyenne Wells, Colorado, 80810, United States
Kaiser Permanente-Franklin
Denver, Colorado, 80205, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Health Center - Brownstown
Brownstown, Michigan, 48183, United States
Henry Ford Health Center - Chesterfield
Chesterfield, Michigan, 48047, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Medical Center - Detroit Northwest
Detroit, Michigan, 48235, United States
Henry Ford Medical Center-Cottage
Grosse Pointe Farms, Michigan, 48236, United States
Henry Ford Medical Center - Livonia
Livonia, Michigan, 48150, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Henry Ford Medical Center - Plymouth
Plymouth, Michigan, 48170, United States
Henry Ford Medical Center - Royal Oak
Royal Oak, Michigan, 48067, United States
Henry Ford Medical Center
Sterling Heights, Michigan, 48310, United States
Henry Ford Medical Center - Troy
Troy, Michigan, 48083, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Sentara Martha Jefferson Hospital
Charlottesville, Virginia, 22911, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott D Ramsey
Fred Hutchinson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2025
First Posted
May 30, 2025
Study Start
June 18, 2025
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.