Cancer Stage Shifting Registry and Biobank to Address Health Disparities
The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health Disparities in Cancer Care
This project will collect health information and blood and saliva samples from adults 35 and older, especially people from historically underrepresented communities, to help find and reduce barriers to early cancer detection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100000 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | National Minority Quality Forum Academic / other |
| Locations | 2 sites (Flint, Michigan and 1 other locations) |
| Trial ID | NCT07461493 on ClinicalTrials.gov |
What this trial studies
The initiative creates a patient registry and biorepository that will enroll adults aged 35 and older to collect medical history, social determinants of health, and biologic samples. Participants will complete questionnaires, allow electronic health record review, and provide blood and saliva during scheduled clinic visits. Enrolled individuals are asked to attend at least one annual assessment per year for five years to support longitudinal research. The resource is intended to support Cancer Early Detection (CED) screening efforts and future studies focused on communities at increased risk for cancer.
Who should consider this trial
Good fit: Ideal candidates are adults 35 years or older who can give informed consent, are willing to share EHR data and complete annual visits and questionnaires, and can provide blood and saliva samples when requested.
Not a fit: People seeking immediate cancer treatment, those unable or unwilling to provide informed consent or biological samples, pregnant individuals, or those medically unable to give blood may not receive direct benefit from participation.
Why it matters
Potential benefit: If successful, this resource could help identify why some communities have later-stage cancer and improve access to earlier screening and detection tools.
How similar studies have performed: Other registries and biobanks have supported advances in early cancer detection and biomarker research, though focused efforts on historically underrepresented populations are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Registry Inclusion Criteria: 1. Adults 35 years and older. 2. Participant provides written informed consent prior to initiation of any study procedures. 3. Participant understands the purpose and procedures of the study. 4. Participant agrees that demographic data, medical history, and social determinants of health on the enrollment questionnaires can be used for research purposes. 5. Participant agrees to the release and review of their electronic medical record. 6. Participant agrees to be followed for the duration outlined in this protocol. Biorepository 1. 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. 2. Participant is a healthy, nonpregnant adult. 3. Participant weighs at least 110 pounds. 4. Participant has negative viral test results. Exclusion Criteria: Registry 1. Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent. 2. Participants who are unable to understand the study protocol or unable to give informed consent. 3. Participants under the age of 35 at the time of enrollment. Biorepository 1. Women of childbearing age that think they may be pregnant or are planning to get pregnant within the study timeframe. 2. Participants who weigh under 110 pounds. 3. Participants who, in the opinion of the investigator, are unable to provide biospecimen samples.
Where this trial is running
Flint, Michigan and 1 other locations
- Life in 3D Health Services — Flint, Michigan, United States (Recruiting)
- Grace Clinic — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.