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

The number of participants enrolled into the study compared to trial goals.

The proportion of participants who are complete questionnaires and timing of completion.

The proportion of participants who have a second blood draw and the timing of the blood draw.

The proportion of participants who do not complete study procedures and are not able to be contacted.

Meeting or exceeding the trial enrollment goals on a population basis.

Advantages and challenges arising from trial activation with one intervention arm and later addition of a second intervention arm.

Comparisons between blinded and unblinded sites on participation rates, adherence to protocol-required questionnaires and blood collection, and participation in standard of care screening.

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 that contribute to the inability to determine if a participant has a cancer or rule out cancer.

Estimated as the number of participants receiving MCD testing outside the trial.

Feasibility outcomes will be reported by participant demographics and cancer risk factors.

The proportion of participants with a "cancer diagnosis" or "no cancer diagnosis" among all participants with an abnormal MCD test result

The number of days from date of ACCESS Hub receipt of abnormal MCD test result to date of provider-reported diagnostic resolution.

The proportion of participants that receive standard of care cancer screening in each arm.

The proportion of diagnosed cancers that match the tissue of origin predicted by an abnormal (positive) MCD test, for each screening episode.

Adverse events occurring in participants undergoing a diagnostic workup following receipt of an abnormal MCD test result.

Participant anxiety will be assessed with the Patient Reported Outcomes Measurement Information System instrument. Cancer-related worry will be assessed using the Lehrman Cancer Worry Scale.

Sensitivity will be estimated for each MCD assay. These sensitivities will also be calculated by early- versus late-stage, and for MCD test-targeted cancers and all cancers.

Specificity will be estimated for each MCD assay.

The proportion of abnormal MCD tests at each screening episode, and the proportion of participants with at least one abnormal test.

The number of participants with an abnormal MCD test and no cancer diagnosis.

The proportion of abnormal MCD tests that result in diagnosis of one of the MCD test-targeted cancers among participants with at least one abnormal test, for each screening episode.

The proportion of abnormal MCD tests that result in diagnosis of any cancer among participants with at least one abnormal test, for each screening episode.

The number of MCD test-targeted cancer cases diagnosed within 12 months of a normal MCD test result among participants who received an MCD test, for each screening episode.

The number of cancer cases diagnosed within a 12-month follow-up period of an abnormal test result among participants who received an MCD test, for each screening episode.

The proportion of normal MCD tests that did not result in diagnosis of one of the MCD test-targeted cancers among participants with a normal test, for each screening episode.

The stage that a cancer was diagnosed (Surveillance, Epidemiology, and End Results [SEER]).

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).

The fraction of MCD-targeted cancers diagnosed during trial participation that resulted in death.

The fraction of all cancers diagnosed during trial participation that resulted in death.

The probability of participant death by any cause during trial participation, by arm.

Will estimate average screening costs associated with MCD testing, evaluation of abnormal MCD tests, standard of care screening and evaluation of abnormal standard of care screening results (all MCD arm participants are encouraged to receive standard of care screening), plus cancer site and stage specific treatment costs sourced from the published literature.

Portions of direct medical care costs paid directly by participants (e.g., copays, deductibles and uncovered medical bills) and direct non-medical participant costs; for example, transportation costs, travel time and distance, accommodation costs, childcare or elder-care costs will be elicited through an adapted version of the Costs for Patients Questionnaire.

Participant and caregiver time spent away from work will be estimated using an adapted version of the Productivity Cost Questionnaire. The dollar value of hours recorded for participant work loss and caregiver time will be estimated using wages from the Bureau of Labor Statistics.

Will evaluate the proportion of participants who complete the Military Exposure Questionnaire, among those who reported military service.