Vanguard: a new blood test approach to screen for multiple cancers
The Vanguard Study: Testing a New Way to Screen for Cancer
This study will test two different blood-based multi-cancer detection tests in adults 45–75 without cancer to see if they find cancers earlier than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24000 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | National Cancer Institute (NCI) NIH |
| Locations | 37 sites (Pleasanton, California and 36 other locations) |
| Trial ID | NCT06995898 on ClinicalTrials.gov |
What this trial studies
This randomized feasibility study will enroll adults aged 45–75 without a recent cancer diagnosis and assign them to one of two multi-cancer detection (MCD) blood-test groups or a control group receiving usual care. Participants will provide blood at enrollment and again at one year, and researchers will collect medical record data to track results, follow-up diagnostics, and standard screening behaviors. The trial focuses on feasibility outcomes—recruitment, adherence, representativeness across sites, timeliness of result return, and diagnostic resolution of abnormal tests—rather than definitive effectiveness. Results will guide design and procedures for a larger randomized trial of MCD screening.
Who should consider this trial
Good fit: Adults 45–75 years old without a solid or blood cancer diagnosis in the past five years who can give blood samples and complete consent and questionnaires in English, Spanish, or Arabic are ideal candidates.
Not a fit: People currently undergoing cancer diagnostic work-up, those with a recent (within five years) cancer diagnosis, those who are pregnant or breastfeeding, or those already in another investigational cancer screening study are not eligible and would not benefit from participating.
Why it matters
Potential benefit: If successful, these blood tests could help find cancers earlier, potentially improving treatment options and outcomes for patients.
How similar studies have performed: Several observational studies of blood-based multi-cancer detection tests have shown promising ability to detect multiple cancer types, but randomized trials proving reduced cancer deaths or clear benefit are still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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
Where this trial is running
Pleasanton, California and 36 other locations
- Kaiser Permanente-Division of Research — Pleasanton, California, United States (Recruiting)
- Keefe Memorial Hospital — Cheyenne Wells, Colorado, United States (Recruiting)
- Kaiser Permanente-Franklin — Denver, Colorado, United States (Recruiting)
- Poudre Valley Hospital — Fort Collins, Colorado, United States (Recruiting)
- Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States (Recruiting)
- UCHealth Greeley Hospital — Greeley, Colorado, United States (Recruiting)
- Kaiser Permanente-Rock Creek — Lafayette, Colorado, United States (Recruiting)
- Kaiser Permanente-Lone Tree — Lone Tree, Colorado, United States (Recruiting)
- Medical Center of the Rockies — Loveland, Colorado, United States (Recruiting)
- Kaiser Permanente Moanalua Medical Center — Honolulu, Hawaii, United States (Recruiting)
- Henry Ford Cancer Institute-Downriver — Brownstown, Michigan, United States (Recruiting)
- Henry Ford Health Center - Brownstown — Brownstown, Michigan, United States (Recruiting)
- Henry Ford Health Center - Chesterfield — Chesterfield, Michigan, United States (Recruiting)
- Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan, United States (Recruiting)
- Henry Ford Medical Center-Fairlane — Dearborn, Michigan, United States (Recruiting)
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Henry Ford Medical Center - Detroit Northwest — Detroit, Michigan, United States (Recruiting)
- Henry Ford Medical Center-Cottage — Grosse Pointe Farms, Michigan, United States (Recruiting)
- Henry Ford Medical Center - Livonia — Livonia, Michigan, United States (Recruiting)
- Henry Ford Medical Center-Columbus — Novi, Michigan, United States (Recruiting)
- Henry Ford Medical Center - Plymouth — Plymouth, Michigan, United States (Recruiting)
- Henry Ford Medical Center - Royal Oak — Royal Oak, Michigan, United States (Recruiting)
- Henry Ford Medical Center — Sterling Heights, Michigan, United States (Recruiting)
- Henry Ford Medical Center - Troy — Troy, Michigan, United States (Recruiting)
- Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States (Recruiting)
- Henry Ford Wyandotte Hospital — Wyandotte, Michigan, United States (Recruiting)
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Sentara Martha Jefferson Hospital — Charlottesville, Virginia, United States (Recruiting)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)
- Inova Fair Oaks Hospital — Fairfax, Virginia, United States (Recruiting)
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Recruiting)
- VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States (Recruiting)
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States (Recruiting)
- VCU Community Memorial Health Center — South Hill, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Scott D Ramsey — Fred Hutchinson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.