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

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).

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (40)

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