The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health Disparities in Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100,000
- 试验地点
- 2
- 主要终点
- Establish a patient registry
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Establish a patient registry
时间窗: 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.
次要结局
- Establish a biorepository(From enrollment to the end of follow up at 10 years.)