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

April 6, 2026 updated by: National Minority Quality Forum

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Flint, Michigan, United States, 48507
        • Recruiting
        • Life in 3D Health Services
        • Contact:
        • Principal Investigator:
          • Rockefeller Oteng, MD
        • Sub-Investigator:
          • Denika Dalton, DNP-C
    • Texas
      • Houston, Texas, United States, 77026
        • Recruiting
        • Grace Clinic
        • Principal Investigator:
          • Chi Si Choi, MD
        • Sub-Investigator:
          • Sheila Young, FNP-BC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants ages 35 years and older from underserved communities, populations living near Superfund sites, designated cancer clusters, and areas affected by industrial contamination to be followed longitudinally over a decade to track cancer screenings and early detection of cancer. Sites will recruit and accrue patients from their clinic sites or at community outreach events community events, churches, health fairs, Federally Qualified Health Centers (FQHCs) and other venues.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Average Cancer Risk
Participants who are 35 years of age or older and have no identified cancer risk factors will be classified into the average-risk cohort.
High Cancer Risk
Participants who are 35 years of age or older and have one or more cancer risk factors will be classified into the high-risk cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow up at 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow up at 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Minority Quality Forum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

March 1, 2034

Study Completion (Estimated)

March 1, 2039

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSSI-ED-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Decision to share and what to share is pending. Ultimately, if decision to share in the future is confirmed to be 'Yes,' all opportunities will be evaluated in accordance with applicable regulations and ethical considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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