Recruiting

Observational Study

Sponsor:

National Minority Quality Forum

Code:

NCT07461493

Conditions

Cancer

Cancer Comorbidities

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07461493

Start date

Mar 11, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2039

Anticipated

Primary completion date

Mar, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

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 Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Establish a patient registry [ Time Frame: From enrollment to the end of follow up at 10 years. ]

Central Contacts and Locations

Locations

Life in 3D Health Services

Recruiting

Flint, Michigan, United States, 48507

Contacts

Denika Dalton, DNP-C

810-780-4189Denika@lifeinddd.com

Principal Investigator:

Rockefeller Oteng, MD

Grace Clinic

Recruiting

Houston, Texas, United States, 77026

Contacts

Sheila Young, FNP-BC

713-993-6000appt@graceclinichouston.com

Principal Investigator:

Chi Si Choi, MD

More Information

Sponsor

National Minority Quality Forum

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Minority Quality Forum on 2026-04-08.