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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Other, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Kaiser Permanente-Division of Research
RECRUITING
Pleasanton
Colorado
Kaiser Permanente-Franklin
RECRUITING
Denver
Kaiser Permanente-Rock Creek
RECRUITING
Lafayette
Kaiser Permanente-Lone Tree
RECRUITING
Lone Tree
Michigan
Henry Ford Cancer Institute-Downriver
RECRUITING
Brownstown
Henry Ford Macomb Hospital-Clinton Township
RECRUITING
Clinton Township
Henry Ford Medical Center-Fairlane
RECRUITING
Dearborn
Henry Ford Hospital
RECRUITING
Detroit
Henry Ford Medical Center - Detroit Northwest
RECRUITING
Detroit
Henry Ford Medical Center-Cottage
RECRUITING
Grosse Pointe Farms
Henry Ford Medical Center - Livonia
RECRUITING
Livonia
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Henry Ford Medical Center - Plymouth
RECRUITING
Plymouth
Henry Ford Medical Center - Royal Oak
RECRUITING
Royal Oak
Henry Ford Medical Center
RECRUITING
Sterling Heights
Henry Ford Medical Center - Troy
RECRUITING
Troy
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Henry Ford Wyandotte Hospital
RECRUITING
Wyandotte
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Virginia
Sentara Martha Jefferson Hospital
RECRUITING
Charlottesville
Inova Fair Oaks Hospital
RECRUITING
Fairfax
Inova Schar Cancer Institute
RECRUITING
Fairfax
Sentara Norfolk General Hospital
RECRUITING
Norfolk
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
VCU Community Memorial Health Center
RECRUITING
South Hill
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 24000
Treatments
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. (This arm is not yet open)
Active_comparator: Arm III (Control)
Participants undergo blood collection at enrollment and after one year on study.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov