The Vanguard Study: Testing a New Way to Screen for Cancer
Purpose
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).
Conditions
- Bladder Carcinoma
- Breast Carcinoma
- Colorectal Carcinoma
- Esophageal Carcinoma
- Gastric Carcinoma
- Liver Carcinoma
- Lung Carcinoma
- Malignant Solid Neoplasm
- Ovarian Carcinoma
- Pancreatic Carcinoma
- Prostate Carcinoma
Eligibility
- Eligible Ages
- Between 45 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Screening
- Masking
- Single (Participant)
- Masking Description
- Four ACCESS Hubs will institute participant blinding to their randomly assigned group. Participants recruited in the remaining ACCESS Hubs will be told the arm to which they have been assigned. The purpose of having some Hubs institute blinding and others unblinded is to assess the impact of blinding on recruitment, participation in standard of care cancer screening, and adherence to the study protocol.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (Shield MCD test) |
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing. |
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Experimental Arm II (Avantect MCD test) |
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing. |
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Active Comparator Arm III (Control) |
Participants undergo blood collection at enrollment and after one year on study. |
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Recruiting Locations
Pleasanton, California 94588
Site Public Contact
510-891-3400
Cheyenne Wells, Colorado 80810
Denver, Colorado 80205
Fort Collins, Colorado 80524
Site Public Contact
970-297-6150
Fort Collins, Colorado 80528
Greeley, Colorado 80631
Lafayette, Colorado 80026
Lone Tree, Colorado 80124
Loveland, Colorado 80538
Site Public Contact
970-203-7083
Honolulu, Hawaii 96819
Brownstown, Michigan 48183
Brownstown, Michigan 48183
Chesterfield, Michigan 48047
Clinton Township, Michigan 48038
Dearborn, Michigan 48126
Detroit, Michigan 48202
Detroit, Michigan 48235
Grosse Pointe Farms, Michigan 48236
Site Public Contact
313-916-1784
Livonia, Michigan 48150
Novi, Michigan 48377
Plymouth, Michigan 48170
Royal Oak, Michigan 48067
Sterling Heights, Michigan 48310
Troy, Michigan 48083
West Bloomfield, Michigan 48322
Kansas City, Missouri 64111
St Louis, Missouri 63110
Chapel Hill, North Carolina 27599
Oklahoma City, Oklahoma 73104
Charlottesville, Virginia 22911
Site Public Contact
434-654-8400
Fairfax, Virginia 22031
Fairfax, Virginia 22033
Norfolk, Virginia 23507
Site Public Contact
757-388-2406
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
More Details
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Study Contact
Detailed Description
PRIMARY OBJECTIVES: I. Assess the feasibility of recruitment and adherence to protocol-required baseline and follow-up data and blood collection. II. Assess the feasibility of achieving representative enrollment across participating recruitment sites. SECONDARY OBJECTIVES: I. To assess the impact of participant blinding on willingness to participate, adherence to protocol required baseline and follow-up data, blood collection, and rates of standard of care screening. II. To determine the timeliness of returning test results to participants. III. To understand the factors contributing to lack of diagnostic resolution of an abnormal MCD test. IV. To examine the effects of participant characteristics, including cancer risk factors and social determinants of health, on all aspects of feasibility. V. To estimate the proportion of participants receiving an MCD test outside of the trial. VI. To assess the feasibility of a staggered introduction of the second MCD assay intervention arm. VII. To estimate the proportion of abnormal MCD tests that are diagnostically resolved, and the time to resolution. VIII. To compare the proportion of participants who receive standard of care screening during follow-up between the intervention and control arms. IX. To assess the accuracy of tissue of origin prediction for each MCD assay. X. To estimate the incidence of complications related to diagnostic evaluation of an abnormal MCD test result. XI. To assess the effect of an abnormal MCD test and diagnostic workup on anxiety and cancer worry. XII. To evaluate the clinical diagnostic performance of the MCD assays. EXPLORATORY OBJECTIVES: I. To estimate rates of late-stage cancer, and the distribution of cancer stage. II. To estimate assay-targeted cancer-specific mortality of each MCD assay, all cancer-specific mortality, and all-cause mortality. OUTLINE: Participants are randomized to 1 of 3 arms. ARM I: Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing. ARM II: Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing. ARM III (Control): Participants undergo blood collection at enrollment and after one year on study. After completion of study intervention, participants are followed passively up to 10 years.