Overview
The goal of this observational study is to establish a patient registry and a biorepository (sample collection and storage) to investigate health disparities, access, and barriers to cancer screening and early detection technologies. The registry and biorepository will serve as a resource to support Cancer Early Detection (CED) screenings and future research focused on communities at increased risk for cancer.
The study seeks to address:
•Barriers and disparities in cancer prevention, screening, and treatment, particularly in historically underrepresented populations.
Participants will:
- Attend a minimum of five clinic visits over a five-year period for scheduled annual assessments while actively enrolled in the study.
- Complete questionnaires at each visit that collect information on their medical history, cancer history, and family cancer history.
- Allow relevant health information from their electronic health records (EHR) to be collected and reviewed.
- Provide blood, saliva, and stool samples for research purposes.
- Enter a long-term follow-up period for an additional five years.
Eligibility
Registry
Inclusion Criteria:
- Adults 35 years and older.
- Participant provides written informed consent prior to initiation of any study procedures.
- Participant understands the purpose and procedures of the study.
- Participant agrees that demographic data, medical history, and social determinants of health on the enrollment questionnaires can be used for research purposes.
- Participant agrees to the release and review of their electronic medical record.
- Participant agrees to be followed for the duration outlined in this protocol.
Biorepository
- Participant is able, in the investigator's professional opinion, to provide up to 100 mLs of whole blood at the Screening Visit and at the Interim Visits.
- Participant is a healthy, nonpregnant adult.
- Participant weighs at least 110 pounds.
- Participant has negative viral test results.
Exclusion Criteria:
Registry
- Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
- Participants who are unable to understand the study protocol or unable to give informed consent.
- Participants under the age of 35 at the time of enrollment.
Biorepository
- Women of childbearing age that think they may be pregnant or are planning to get pregnant within the study timeframe.
- Participants who weigh under 110 pounds.
- Participants who, in the opinion of the investigator, are unable to provide biospecimen samples.


