用于胰腺癌诊断的表观遗传学检测方法的特征开发与验证方案
用于诊断胰腺癌的表观遗传学检测的签名开发和验证方案
The purpose of this research study is to test a new process for diagnosing pancreatic 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.
研究概览
地位
条件
详细说明
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 pancreatic 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:
- Pancreatic cancer, NO chemotherapy. Surgical resection and/or radiation therapy
- Pancreatic cancer, WITH chemotherapy. All stages including remission
- At risk group (individuals who have chronic pancreatitis, been diagnosed with an intraductal papillary mucinous neoplasm (IPMN), have a family history of pancreatic cancer and/or have a known genetic disposition)
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Jennifer Emel, MA
- 电话号码：410-553-8048
- 邮箱：Jennifer.Emel@umm.edu
研究联系人备份
- 姓名：Sade Bademosi
- 电话号码：410-553-8188
- 邮箱：Sade.Bademosi@umm.edu
学习地点
-
-
Maryland
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Glen Burnie、Maryland、美国、21061
- University of Maryland Baltimore Washington Medical Center
-
接触：
- Peter Olivieri, MD
- 电话号码：410-553-8241
- 邮箱：polivieri@umm.edu
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副研究员：
- Jeffrey Marshall, MD
-
副研究员：
- Harvinder Singh, MD
-
副研究员：
- Agazi Gebreselassie, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Study participants will be selected from patients being cared for across the University of Maryland Medical System
描述
Inclusion Criteria:
- 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
- Has a history of pancreatic cancer of is at high risk for pancreatic cancer
Exclusion Criteria:
- 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
- Does not have a history of pancreatic cancer or is not at high risk for pancreatic cancer
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Study Population 1
This study population will consist of individuals who have a diagnosis of pancreatic cancer and have not received chemotherapy treatment for their pancreatic cancer. Individuals who have received surgical resection and/or radiation therapy for their pancreatic cancer will be included. |
|
Study Population 2
This study population will consist of individuals who have a diagnosis of pancreatic cancer and have received chemotherapy treatment for their pancreatic cancer. All stages of pancreatic cancer will be included including individuals in remission. |
|
Study Population 3
This study population will consist of individuals who are at high risk of developing pancreatic cancer. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Identification of tumor-associated host methylation signature
大体时间：5 years
|
Genome-wide methylation profile of whole blood from pancreatic cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects. |
5 years
|
|
Technology development
大体时间：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. |
5 years
|
|
Technology validation
大体时间：5 years
|
The investigators will validate identified blood-based circulating methylation signatures in patients at high risk for developing pancreatic cancer. |
5 years
|
合作者和调查者
出版物和有用的链接
一般刊物
- Li Y, Fan Z, Meng Y, Liu S, Zhan H. Blood-based DNA methylation signatures in cancer: A systematic review. Biochim Biophys Acta Mol Basis Dis. 2023 Jan 1;1869(1):166583. doi: 10.1016/j.bbadis.2022.166583. Epub 2022 Oct 18.
- Terp SK, Stoico MP, Dybkaer K, Pedersen IS. Early diagnosis of ovarian cancer based on methylation profiles in peripheral blood cell-free DNA: a systematic review. Clin Epigenetics. 2023 Feb 14;15(1):24. doi: 10.1186/s13148-023-01440-w.
- Ibrahim J, Peeters M, Van Camp G, Op de Beeck K. Methylation biomarkers for early cancer detection and diagnosis: Current and future perspectives. Eur J Cancer. 2023 Jan;178:91-113. doi: 10.1016/j.ejca.2022.10.015. Epub 2022 Oct 27.
- Guo Y, Yin J, Dai Y, Guan Y, Chen P, Chen Y, Huang C, Lu YJ, Zhang L, Song D. A Novel CpG Methylation Risk Indicator for Predicting Prognosis in Bladder Cancer. Front Cell Dev Biol. 2021 Sep 1;9:642650. doi: 10.3389/fcell.2021.642650. eCollection 2021.
- Xie Y, Li P, Sun D, Qi Q, Ma S, Zhao Y, Zhang S, Wang T, Wang J, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Wang C, Du L. DNA Methylation-Based Testing in Peripheral Blood Mononuclear Cells Enables Accurate and Early Detection of Colorectal Cancer. Cancer Res. 2023 Nov 1;83(21):3636-3649. doi: 10.1158/0008-5472.CAN-22-3402.
- Wang T, Li P, Qi Q, Zhang S, Xie Y, Wang J, Liu S, Ma S, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Du L, Wang C. A multiplex blood-based assay targeting DNA methylation in PBMCs enables early detection of breast cancer. Nat Commun. 2023 Aug 7;14(1):4724. doi: 10.1038/s41467-023-40389-5.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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