The Vanguard Study: Testing a New Way to Screen for Cancer
Recruiting · NCT06995898 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionDevice UsageElectronic Health Record ReviewMulti-Cancer Detection TestQuestionnaire Administration
What this trial is about
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).
Who can take part
Age range
45 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 13 US states.
- Kaiser Permanente-Division of Research - Pleasanton, California, United States
- Kaiser Permanente-Division of Research - Pleasanton, California, United States
- Kaiser Permanente-Division of Research - Pleasanton, California, United States
- Keefe Memorial Hospital - Cheyenne Wells, Colorado, United States
- Keefe Memorial Hospital - Cheyenne Wells, Colorado, United States
- Keefe Memorial Hospital - Cheyenne Wells, Colorado, United States
- Kaiser Permanente-Franklin - Denver, Colorado, United States
- Kaiser Permanente-Franklin - Denver, 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
- Poudre Valley Hospital - Fort Collins, Colorado, United States
- Cancer Care and Hematology-Fort Collins - Fort Collins, 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
- UCHealth Greeley Hospital - Greeley, Colorado, United States
- UCHealth Greeley Hospital - Greeley, Colorado, United States
- Kaiser Permanente-Rock Creek - Lafayette, Colorado, United States
- Kaiser Permanente-Rock Creek - Lafayette, Colorado, United States
- Kaiser Permanente-Rock Creek - Lafayette, Colorado, United States
- Kaiser Permanente-Lone Tree - Lone Tree, Colorado, United States
- Kaiser Permanente-Lone Tree - Lone Tree, Colorado, United States
- Kaiser Permanente-Lone Tree - Lone Tree, Colorado, United States
- Medical Center of the Rockies - Loveland, Colorado, United States
- Medical Center of the Rockies - Loveland, Colorado, United States
- Medical Center of the Rockies - Loveland, Colorado, United States
- Kaiser Permanente Moanalua Medical Center - Honolulu, Hawaii, United States
- Kaiser Permanente Moanalua Medical Center - Honolulu, Hawaii, United States
- Kaiser Permanente Moanalua Medical Center - Honolulu, Hawaii, United States
- Walter Reed National Military Medical Center - Bethesda, Maryland, United States
- Walter Reed National Military Medical Center - Bethesda, Maryland, 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 Cancer Institute-Downriver - Brownstown, Michigan, United States
- Henry Ford Health Center - Brownstown - Brownstown, Michigan, 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 Health Center - Chesterfield - Chesterfield, 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 Macomb Hospital-Clinton Township - Clinton Township, 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 Medical Center-Fairlane - Dearborn, 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 Hospital - Detroit, Michigan, United States
- Henry Ford Medical Center - Detroit Northwest - Detroit, 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-Cottage - Grosse Pointe Farms, 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 - Livonia - Livonia, Michigan, United States
- Henry Ford Medical Center - Livonia - Livonia, Michigan, United States
Showing 60 of 132 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →