Recruiting

Multi-Cancer DetectionThe Vanguard Study: Testing a New Way to Screen for Cancer

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06995898

Conditions

Bladder Carcinoma

Breast Carcinoma

Colorectal Carcinoma

Esophageal Carcinoma

Gastric Carcinoma

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Device Usage

Electronic Health Record Review

Multi-Cancer Detection Test

Study Details

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).

Conditions

Bladder Carcinoma

Breast Carcinoma

Colorectal Carcinoma

Esophageal Carcinoma

Gastric Carcinoma

Study ID

NCT06995898

Start date

Jun 18, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred
Ongoing cancer diagnostic work-up
Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice
Currently breastfeeding or pregnant, or planning to become pregnant in the next year
History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days

Study Design

Enrollment

24000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo blood collection

Device Usage

Evaluation of MCD tests

Electronic Health Record Review

Obtain health data

Multi-Cancer Detection Test

Undergo Shield MCD test

Multi-Cancer Detection Test

Undergo Avantect MCD test

Questionnaire Administration

Study specific questionnaires

Primary outcome measure

Feasibility of enrollment onto study [ Time Frame: At time of randomization ]
Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt [ Time Frame: 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 [ Time Frame: Up to 2 years ]
Proportion of participants considered lost to follow-up within 2 years of randomization [ Time Frame: Up to 2 years ]
Representative enrollment [ Time Frame: Up to 2 years ]
Staggered start of intervention arm 2 [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Locations

Kaiser Permanente-Division of Research

Recruiting

Pleasanton, California, United States, 94588

Contacts

Site Public Contact

510-891-3400

Principal Investigator:

Jeffrey Lee

Keefe Memorial Hospital

Recruiting

Cheyenne Wells, Colorado, United States, 80810

Contacts

Site Public Contact

719-767-5661 cmillsap@keefemh.org

Principal Investigator:

Linda S. Cook

Kaiser Permanente-Franklin

Recruiting

Denver, Colorado, United States, 80205

Contacts

Site Public Contact

303-817-9295 KPCOIHRClinicalResearch@kp.org

Principal Investigator:

Debra P. Ritzwoller

Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Site Public Contact

970-297-6150

Principal Investigator:

Linda S. Cook

Cancer Care and Hematology-Fort Collins

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Site Public Contact

888-823-5923 ctsucontact@westat.com

Principal Investigator:

Linda S. Cook

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Site Public Contact

888-823-5923 ctsucontact@westat.com

Principal Investigator:

Linda S. Cook

Kaiser Permanente-Rock Creek

Recruiting

Lafayette, Colorado, United States, 80026

Contacts

Site Public Contact

303-817-9295 KPCOIHRClinicalResearch@kp.org

Principal Investigator:

Debra P. Ritzwoller

Kaiser Permanente-Lone Tree

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Site Public Contact

303-817-9295 KPCOIHRClinicalResearch@kp.org

Principal Investigator:

Debra P. Ritzwoller

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Site Public Contact

970-203-7083

Principal Investigator:

Linda S. Cook

Kaiser Permanente Moanalua Medical Center

Recruiting

Honolulu, Hawaii, United States, 96819

Contacts

Site Public Contact

808-432-5195 shelley.a.clark@kp.org

Principal Investigator:

Stacey Honda

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Kristen Natale

Henry Ford Cancer Institute-Downriver

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Health Center - Brownstown

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Site Public Contact

313-874-5472 CDUDAS1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Health Center - Chesterfield

Recruiting

Chesterfield, Michigan, United States, 48047

Contacts

Site Public Contact

313-874-5472 CDUDAS1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center-Fairlane

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center - Detroit Northwest

Recruiting

Detroit, Michigan, United States, 48235

Contacts

Site Public Contact

kkeenan1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center-Cottage

Recruiting

Grosse Pointe Farms, Michigan, United States, 48236

Contacts

Site Public Contact

313-916-1784

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center - Livonia

Recruiting

Livonia, Michigan, United States, 48150

Contacts

Site Public Contact

kkeenan1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center - Plymouth

Recruiting

Plymouth, Michigan, United States, 48170

Contacts

Site Public Contact

kkeenan1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center - Royal Oak

Recruiting

Royal Oak, Michigan, United States, 48067

Contacts

Site Public Contact

kkeenan1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center

Recruiting

Sterling Heights, Michigan, United States, 48310

Contacts

Site Public Contact

888-823-5923 ctsucontact@westat.com

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Medical Center - Troy

Recruiting

Troy, Michigan, United States, 48083

Contacts

Site Public Contact

kkeenan1@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Henry Ford Wyandotte Hospital

Recruiting

Wyandotte, Michigan, United States, 48192

Contacts

Site Public Contact

nhay@hfhs.org

Principal Investigator:

Christine Neslund-Dudas

Minneapolis VA Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Site Public Contact

612-467-2800

Principal Investigator:

Mark A. Klein

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Site Public Contact

913-948-5588 aroland@kccop.org

Principal Investigator:

Timothy J. Pluard

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Aimee S. James

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683 cancerclinicaltrials@med.unc.edu

Principal Investigator:

Daniel S. Reuland

Durham VA Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Site Public Contact

919-286-0411 VHADURcancertrials@va.gov

Principal Investigator:

Scott Shofer

Louis Stokes Cleveland VA Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

holly.henry@va.gov

Principal Investigator:

Charles J. Nock

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator:

Mark Doescher

Sentara Martha Jefferson Hospital

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

Site Public Contact

434-654-8400

Principal Investigator:

John M. Sayles

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Site Public Contact

703-720-5210 Stephanie.VanBebber@inova.org

Principal Investigator:

Rebecca D. Kaltman

Inova Fair Oaks Hospital

Recruiting

Fairfax, Virginia, United States, 22033

Contacts

Site Public Contact

703-720-5210 Stephanie.VanBebber@inova.org

Principal Investigator:

Rebecca D. Kaltman

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Site Public Contact

757-388-2406

Principal Investigator:

John M. Sayles

Naval Medical Center - Portsmouth

Recruiting

Portsmouth, Virginia, United States, 23708-2197

Contacts

Site Public Contact

757-953-5939

Principal Investigator:

John C. Mattingly

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

Alexander H. Krist

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430 CTOclinops@vcu.edu

Principal Investigator:

Alexander H. Krist

VCU Community Memorial Health Center

Recruiting

South Hill, Virginia, United States, 23970

Contacts

Site Public Contact

nemer.elmouallem@vcuhealth.org

Principal Investigator:

Alexander H. Krist

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Site Public Contact

253-968-6144 melissa.a.forouhar.mil@health.mil

Principal Investigator:

Matthew Lavoie

Zablocki Veterans Administration Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53295

Contacts

Site Public Contact

888-469-6614

Principal Investigator:

Jeffrey C. Whittle

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-02.