MERIT (Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies) Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data
研究概览
简要总结
This study collects mammogram images, blood samples, and clinical information from women undergoing routine screening mammograms. Creating a bank of blood samples and a database of clinical and risk information may be used in future research related to breast cancer, other cancers, and women's health.
详细描述
PRIMARY OBJECTIVES:
I. To establish a longitudinal cohort (n=10,000) of women who undergo routine annual mammography screening with follow-up for at least five years for each study participant or until breast cancer diagnosis.
II. To create a repository of blood specimens from the cohort to use for biomarker discovery and validation.
III. To create a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data on the study participants.
OUTLINE:
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate in the study and ability to provide informed consent
- •Willingness to complete a questionnaire and to provide a blood sample at the initial visit and at follow up annual visits
- •Undergoing a screening mammogram at participating sites. Subjects undergoing routine annual diagnostic mammograms or CEM as part of a screening study are also eligible.
排除标准
- •Current or recent (within the prior 6 months) history of breast feeding
- •Personal history of breast cancer (ductal breast carcinoma in situ [DCIS] or invasive breast cancer)
- •Personal history of any other cancer (excluding in-situ, stage 0, and non-melanoma skin cancers and other pre-cancerous conditions) treated within the last 5 years.
研究组 & 干预措施
Observational (mammography, questionnaires, blood collection)
Participants complete questionnaires over 15-25 minutes about personal and family history of cancer, health status, breast cancer risk factors, diet, weight gain, and physical activity, and undergo collection of blood samples at baseline and then annually for 5 years. Participants also undergo standard of care mammography at baseline and then annually for 5 years.
干预措施: Biospecimen Collection (Procedure)
Observational (mammography, questionnaires, blood collection)
Participants complete questionnaires over 15-25 minutes about personal and family history of cancer, health status, breast cancer risk factors, diet, weight gain, and physical activity, and undergo collection of blood samples at baseline and then annually for 5 years. Participants also undergo standard of care mammography at baseline and then annually for 5 years.
干预措施: Mammography (Procedure)
Observational (mammography, questionnaires, blood collection)
Participants complete questionnaires over 15-25 minutes about personal and family history of cancer, health status, breast cancer risk factors, diet, weight gain, and physical activity, and undergo collection of blood samples at baseline and then annually for 5 years. Participants also undergo standard of care mammography at baseline and then annually for 5 years.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data
时间窗: 5 years
次要结局
未报告次要终点