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 range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish a patient registry
Timeframe: From enrollment to the end of follow up at 10 years.