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.
Subjects in the Cancer cohort will be identified via nurse navigation, study staff or
oncology physicians in local offices. The nurse navigator or study staff will verify
eligibility through chart review and pre-screen, approach the subject about the study
opportunity, and present the informed consent form. For participants enrolling
electronically, participants will be presented with a secured tablet device on which the
subject will watch a brief video about the study, read the informed consent and provide
electronic consent. Some participants may also have the option of having the video,
informed consent and survey emailed to them. Upon consent and enrollment, subjects will
be assigned a unique subject study ID, which will be used to track the subject, their
data and their biospecimen throughout study operations. Consented subjects will then be
directed to complete a survey via the tablet device, email or paper. Participants will be
allowed to skip questions in the survey or select the answer option "prefer not to
answer." Subject data will be tracked in real-time by central study staff to ensure
desired tumor type diversification and communicate enrollment strategy changes to the
nurse navigators and study staff.
