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).
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
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
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood collection
Device Usage
DeviceEvaluation of MCD tests
Electronic Health Record Review
Other interventionObtain health data
Multi-Cancer Detection Test
Procedure/SurgeryUndergo Shield MCD test
Multi-Cancer Detection Test
Procedure/SurgeryUndergo Avantect MCD test
Questionnaire Administration
Other interventionStudy specific questionnaires
Feasibility of enrollment onto study
The number of participants enrolled into the study compared to trial goals.
Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt
The proportion of participants who are complete questionnaires and timing of completion.
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
The proportion of participants who have a second blood draw and the timing of the blood draw.
Proportion of participants considered lost to follow-up within 2 years of randomization
The proportion of participants who do not complete study procedures and are not able to be contacted.
Impact of participant blinding
Comparisons between blinded and unblinded sites on participation rates, adherence to protocol-required questionnaires and blood collection, and participation in standard of care screening.
Timely return of MCD test result
The time from receipt of the MCD test result at the Statistics and Data Management Center to the time of receipt of the MCD test result at the ACCESS Hub. The time from receipt of MCD test result at the ACCESS Hub to the time of participant receipt of the MCD test result.
Factors contributing to lack of diagnostic resolution of an abnormal MCD test
Factors that contribute to the inability to determine if a participant has a cancer or rule out cancer.
Contamination
Estimated as the number of participants receiving MCD testing outside the trial.
Cancer stage
The stage that a cancer was diagnosed (Surveillance, Epidemiology, and End Results \[SEER\]).
Early and late stages cancer diagnosis
Counts of early and late-stage cancers by arm, separately for each cancer type. Early stage is defined as in situ or localized (SEER). Late stage is defined as regional or distant stage (SEER).
Targeted cancer-specific mortality of each MCD assay
The fraction of MCD-targeted cancers diagnosed during trial participation that resulted in death.
Cancer-specific mortality
The fraction of all cancers diagnosed during trial participation that resulted in death.
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