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

RECRUITINGN/ASponsored by National Cancer Institute (NCI)
Actively Recruiting
PhaseN/A
SponsorNational Cancer Institute (NCI)
Started2025-06-16
Est. completion2027-12-31
Eligibility
Age45 Years – 75 Years
Healthy vol.Accepted
Locations36 sites

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

Age: 45 Years – 75 YearsHealthy 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
* 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

Conditions16

Bladder CarcinomaBreast CancerBreast CarcinomaCancerColorectal CarcinomaEsophageal CarcinomaGastric CarcinomaLiver CancerLiver CarcinomaLiver Disease

Locations36 sites

Kaiser Permanente-Division of Research
Pleasanton, California, 94588
Site Public Contact510-891-3400
Keefe Memorial Hospital
Cheyenne Wells, Colorado, 80810
Site Public Contact719-767-5661cmillsap@keefemh.org
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact303-817-9295KPCOIHRClinicalResearch@kp.org
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact888-823-5923ctsucontact@westat.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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