Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing - Ascertaining Serial Cancer Patients to Enable New Diagnostic

This is a prospective, observational study of 1,000 subjects with known or suspected cancer confirmed through pathology reports and/or clinical/radiographic data and 2,000 subjects with no known cancer. De-identified blood samples and clinical data will be collected from subjects to validate a classification algorithm for a new version of the CancerSEEK assay.

Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician to document screening including date of upcoming therapy or surgery for cancer patients if one has been scheduled, before providing informed consent to participate in the study. Study procedures outside of the pre-screening for eligibility will not be performed prior to the subject providing consent. Informed consent will be carried out in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines. Prior to signing the informed consent form (ICF), potential participants will confirm that they understand the study and that they have no questions about the study.

The ICF may be offered by paper or electronically with the option to also review a paper copy provided by the nurse navigator or study coordinator either face-to-face on a tablet or via email. Potential participants will be given a phone number to call with any study specific questions. Copies of all signed consent forms will be stored centrally in a secure environment, and signed consent forms will thereby be available for verification by Thrive or its designee at any time.

Once the subject completes the survey, study staff will complete the blood draw and collect height and weight data. For some participants, their contact information and unique study identifier (ID) will be sent securely to a third-party vendor who will contact the subject within 24 hours to schedule the blood draw and height and weight measurements at a location convenient to the subject.

For all subjects, study staff and the third-party vendor performing the blood collection will verify the following before performing the blood draw and height and weight measurements: participant identity and age against a form of identification, that consent to participate has been given, that the participants in the cancer arm are still treatment naïve, and that they do not have a fever that could be caused by an infection. The blood collection vendor will ensure all required data are captured and included with the blood sample, that the sample is collected and packaged according to laboratory manual specifications, and that the sample is shipped to the indicated processing lab with the required expediency. Following all study visits, study staff and third party vendor staff will complete a visit checklist confirming all of the study activities that occurred.