The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health Disparities in Cancer Care

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.

Recruiting

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Key information

Conditions

Cancer Cancer Comorbidities Neoplasms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Life in 3D Health Services, Flint, Michigan, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Establish a patient registry

Time frame: From enrollment to the end of follow up at 10 years.

The primary objective of this study is to establish a patient registry that collects and characterizes health data from marginalized and underserved communities.

Secondary outcomes

Establish a biorepository

Time frame: From enrollment to the end of follow up at 10 years.

The secondary objective of this study is to establish a unique biorepository that collects and characterizes biological samples from marginalized and underserved communities. This biorepository will focus on cancer incidence, stage, type, and geography and enable exploratory research towards the development of novel early detection technologies.

Sponsors and collaborators

Lead sponsor

National Minority Quality Forum

Other

Registry information

Acronym: CSSI

Important dates

Study start: 2025
Primary completion: 2034
Study completion: 2039
First posted: Mar 10, 2026
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting