Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Identification of tumor-associated host methylation signature
研究概览
简要总结
The purpose of this research study is to test a new process for diagnosing breast cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future.
Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.
详细描述
This clinical testing protocol outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose breast cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 150 subjects per cohort across 3 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort with include the following patient populations with up to 50 patients per population:
- Breast cancer, NO chemotherapy. Includes patients treated with surgical resection and/or radiation therapy and/or endocrine therapy
- Breast cancer who have received chemotherapy. Includes all stages including remission
- At risk group (patients at increased risk for breast cancer followed in a high risk breast program)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or older
- •Patient of UMMS
- •Willing and able to consent to study procedures listed in the protocol
- •Ability to speak and understand English
排除标准
- •Younger than 18 years old
- •Patient not cared for at UMMS
- •Unable to consent to study procedures listed in the protocol
- •Unable to speak or understand English
研究组 & 干预措施
Study Population 3
This study population will consist of individuals who are at high risk of developing breast cancer.
干预措施: Epigenetic Assay (Other)
Study Population 1
This study population will consist of individuals who have a diagnosis of breast cancer and have not received chemotherapy treatment for their breast cancer. Individuals who have received surgical resection and/or radiation therapy and/or endocrine therapy for their breast cancer will be included.
干预措施: Epigenetic Assay (Other)
Study Population 2
This study population will consist of individuals who have a diagnosis of breast cancer and have received chemotherapy treatment for their breast cancer. All stages of breast cancer will be included including individuals in remission.
干预措施: Epigenetic Assay (Other)
结局指标
主要结局
Identification of tumor-associated host methylation signature
时间窗: 5 years
Genome-wide methylation profile of whole blood from lung cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.
Technology development
时间窗: 5 years
The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.
Technology validation
时间窗: 5 years
The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.
次要结局
- EORTC QLQ-C30 Questionnaire(5 years)
- EORTC QLQ-BR45 Questionnaire(5 years)
- SF-36v2 Questionnaire(5 years)
研究者
Peter Olivieri
Chair, Division of Pulmonary & Critical Care; Director, Interventional Pulmonary Program
University of Maryland, Baltimore