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

Обзор

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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Establish a biorepository [Срок оценки: From enrollment to the end of follow up at 10 years.]

Критерии участия

Registry

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Life in 3D Health Services — Flint
• Grace Clinic — Houston

Идентификаторы

NCT: NCT07461493 · CSSI-ED-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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