The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health D… (NCT07461493) | Clinical Trial Compass
RecruitingNot Applicable
The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health Disparities in Cancer Care
United States100,000 participantsStarted 2025-03-11
Plain-language summary
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.
Who can participate
Age range35 Years
SexALL
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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.
✓. 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.
Exclusion criteria
✕. Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
What they're measuring
1
Establish a patient registry
Timeframe: From enrollment to the end of follow up at 10 years.