Recruiting

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

ClinicalTrials.gov IDNCT06995898

PhaseNA

Enrollment24000

SponsorNational Cancer Institute (NCI)

Age45 Years

SexALL

I'm interested View official listing

Conditions studied

Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Liver Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma

About this study

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).

Interventions

Procedure: Biospecimen Collection — Undergo blood collection
Device: Device Usage — Evaluation of MCD tests
Other: Electronic Health Record Review — Obtain health data
Procedure: Multi-Cancer Detection Test — Undergo Shield MCD test
Procedure: Multi-Cancer Detection Test — Undergo Avantect MCD test
Other: Questionnaire Administration — Study specific questionnaires

Primary outcomes

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

Eligibility information

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 locations

Kaiser Permanente-Division of Research, Pleasanton, California 94588 United States
Keefe Memorial Hospital, Cheyenne Wells, Colorado 80810 United States
Kaiser Permanente-Franklin, Denver, Colorado 80205 United States
Poudre Valley Hospital, Fort Collins, Colorado 80524 United States
Cancer Care and Hematology-Fort Collins, Fort Collins, Colorado 80528 United States
UCHealth Greeley Hospital, Greeley, Colorado 80631 United States
Kaiser Permanente-Rock Creek, Lafayette, Colorado 80026 United States
Kaiser Permanente-Lone Tree, Lone Tree, Colorado 80124 United States
Medical Center of the Rockies, Loveland, Colorado 80538 United States
Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii 96819 United States

Showing 10 of 44 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.