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

NCT07461493 | Recruiting DMC

• 1 other identifier: CSSI-ED-25
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer; Cancer Comorbidities

Keywords

Early Detection; Cancer; Registry; Biorepository; Cancer cluster; CSSI; Cancer Stage Shifting Initiative; NMQF; National Minority Quality Forum; Health Disparities; Oncology; Cancer Screening; Tumor; superfund; environmental risks; SDOH

Outcome Measures

Primary Outcomes (1)

• Establish a patient registry

  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 Outcomes (1)

• Establish a biorepository

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Minority Quality Forum: lead

Study Sites (2)

Life in 3D Health Services

Flint, Michigan, 48507, United States

RECRUITING

Grace Clinic

Houston, Texas, 77026, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Serum, Saliva, Stool

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2039
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (2)