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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06995898

Registry updated: 2026-10-06
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Description

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

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

Eligibility 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. 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

Conditions

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

Locations

  • Kaiser Permanente-Division of Research — Pleasanton, California, United States
  • Keefe Memorial Hospital — Cheyenne Wells, Colorado, United States
  • Kaiser Permanente-Franklin — Denver, Colorado, United States
  • Poudre Valley Hospital — Fort Collins, Colorado, United States
  • Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
  • UCHealth Greeley Hospital — Greeley, Colorado, United States
  • Kaiser Permanente-Rock Creek — Lafayette, Colorado, United States
  • Kaiser Permanente-Lone Tree — Lone Tree, Colorado, United States
  • Medical Center of the Rockies — Loveland, Colorado, United States
  • Kaiser Permanente Moanalua Medical Center — Honolulu, Hawaii, United States
  • Walter Reed National Military Medical Center — Bethesda, Maryland, United States
  • Henry Ford Cancer Institute-Downriver — Brownstown, Michigan, United States
  • Henry Ford Health Center - Brownstown — Brownstown, Michigan, United States
  • Henry Ford Health Center - Chesterfield — Chesterfield, Michigan, United States
  • Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan, United States
  • Henry Ford Medical Center-Fairlane — Dearborn, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Henry Ford Medical Center - Detroit Northwest — Detroit, Michigan, United States
  • Henry Ford Medical Center-Cottage — Grosse Pointe Farms, Michigan, United States
  • Henry Ford Medical Center - Livonia — Livonia, Michigan, United States
  • Henry Ford Medical Center-Columbus — Novi, Michigan, United States
  • Henry Ford Medical Center - Plymouth — Plymouth, Michigan, United States
  • Henry Ford Medical Center - Royal Oak — Royal Oak, Michigan, United States
  • Henry Ford Medical Center — Sterling Heights, Michigan, United States
  • Henry Ford Medical Center - Troy — Troy, Michigan, United States
  • Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States
  • Henry Ford Wyandotte Hospital — Wyandotte, Michigan, United States
  • Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
  • Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
  • CoxHealth South Hospital — Springfield, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Durham VA Medical Center — Durham, North Carolina, United States
  • Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Sentara Martha Jefferson Hospital — Charlottesville, Virginia, United States
  • Inova Schar Cancer Institute — Fairfax, Virginia, United States
  • Inova Fair Oaks Hospital — Fairfax, Virginia, United States
  • Sentara Norfolk General Hospital — Norfolk, Virginia, United States
  • Naval Medical Center - Portsmouth — Portsmouth, Virginia, United States
  • VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • VCU Community Memorial Health Center — South Hill, Virginia, United States
  • Madigan Army Medical Center — Tacoma, Washington, United States
  • Zablocki Veterans Administration Medical Center — Milwaukee, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record