Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
Healthy Volunteers
ID06995898

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

Led by National Cancer Institute (NCI) ยท Updated on 2026-06-01

24000

Participants Needed

37

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating multi-cancer detection (MCD) tests as new tools to screen for multiple cancers at once by measuring markers in the blood. This trial aims to explore how well these tests work for cancer screening, their impact on patients and doctors in making care decisions, and how to conduct such studies in the future. Adults aged 45 to 75 without cancer are included to help assess the feasibility and performance of these MCD tests compared to standard care. Participants are randomly assigned to one of three groups: two groups undergo blood collection for different MCD tests called Shield and Avantect at enrollment and after one year, and a control group undergoes blood collection without MCD testing. Some study sites provide participants with their test results (unblinded) while others only provide abnormal results (blinded). Those with abnormal results are advised to follow up with their clinicians for further testing. After the intervention, participants are followed passively for up to 10 years. Throughout the study, participants complete questionnaires and provide blood samples at specified times. Researchers collect medical record data and monitor adherence to the protocol, timing of test result returns, diagnostic follow-ups for abnormal results, and participants' anxiety and cancer worry. The study measures feasibility outcomes such as enrollment, follow-up completion, and diagnostic resolution, as well as clinical performance of the MCD tests. Safety and long-term outcomes, including cancer incidence and mortality, are also observed.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years
  • 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
  • Note: Persons with a history of in situ cancers or nonmelanoma skin cancer are eligible

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for enrollment and initial blood collection

Surveillance

Duration - 1 year

Participants undergo blood collection for Multi-Cancer Detection (MCD) testing at enrollment and after one year on study. Participants with abnormal results follow up with their clinician for additional testing as needed.

2 visits (in-person) for blood collection at enrollment and at 1 year

Long-term Monitoring

Duration - Up to 10 years

After completion of the initial study intervention, participants are followed passively for up to 10 years to assess outcomes and health status.

No scheduled visits; passive follow-up through health records

Trial Site Locations

Total: 37 locations

1

Kaiser Permanente-Division of Research

Pleasanton, California, United States, 94588

Actively Recruiting

2

Keefe Memorial Hospital

Cheyenne Wells, Colorado, United States, 80810

Actively Recruiting

3

Kaiser Permanente-Franklin

Denver, Colorado, United States, 80205

Actively Recruiting

4

Poudre Valley Hospital

Fort Collins, Colorado, United States, 80524

Actively Recruiting

5

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States, 80528

Actively Recruiting

6

UCHealth Greeley Hospital

Greeley, Colorado, United States, 80631

Actively Recruiting

7

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States, 80026

Actively Recruiting

8

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States, 80124

Actively Recruiting

9

Medical Center of the Rockies

Loveland, Colorado, United States, 80538

Actively Recruiting

10

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States, 96819

Actively Recruiting

11

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States, 48183

Actively Recruiting

12

Henry Ford Health Center - Brownstown

Brownstown, Michigan, United States, 48183

Actively Recruiting

13

Henry Ford Health Center - Chesterfield

Chesterfield, Michigan, United States, 48047

Actively Recruiting

14

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States, 48038

Actively Recruiting

15

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States, 48126

Actively Recruiting

16

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

17

Henry Ford Medical Center - Detroit Northwest

Detroit, Michigan, United States, 48235

Actively Recruiting

18

Henry Ford Medical Center-Cottage

Grosse Pointe Farms, Michigan, United States, 48236

Actively Recruiting

19

Henry Ford Medical Center - Livonia

Livonia, Michigan, United States, 48150

Actively Recruiting

20

Henry Ford Medical Center-Columbus

Novi, Michigan, United States, 48377

Actively Recruiting

21

Henry Ford Medical Center - Plymouth

Plymouth, Michigan, United States, 48170

Actively Recruiting

22

Henry Ford Medical Center - Royal Oak

Royal Oak, Michigan, United States, 48067

Actively Recruiting

23

Henry Ford Medical Center

Sterling Heights, Michigan, United States, 48310

Actively Recruiting

24

Henry Ford Medical Center - Troy

Troy, Michigan, United States, 48083

Actively Recruiting

25

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States, 48322

Actively Recruiting

26

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, United States, 48192

Actively Recruiting

27

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States, 64111

Actively Recruiting

28

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

29

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

30

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

31

Sentara Martha Jefferson Hospital

Charlottesville, Virginia, United States, 22911

Actively Recruiting

32

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

33

Inova Fair Oaks Hospital

Fairfax, Virginia, United States, 22033

Actively Recruiting

34

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Actively Recruiting

35

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States, 23235

Actively Recruiting

36

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

37

VCU Community Memorial Health Center

South Hill, Virginia, United States, 23970

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

3

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