膵臓癌診断のためのエピジェネティックアッセイのシグネチャ開発および検証プロトコル
膵臓癌診断のためのエピジェネティックアッセイにおけるシグネチャー開発および検証プロトコル
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.
調査の概要
状態
詳細な説明
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)
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jennifer Emel, MA
- 電話番号：410-553-8048
- メール：Jennifer.Emel@umm.edu
研究連絡先のバックアップ
- 名前：Sade Bademosi
- 電話番号：410-553-8188
- メール：Sade.Bademosi@umm.edu
研究場所
-
-
Maryland
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Glen Burnie、Maryland、アメリカ、21061
- University of Maryland Baltimore Washington Medical Center
-
コンタクト：
- Peter Olivieri, MD
- 電話番号：410-553-8241
- メール：polivieri@umm.edu
-
副調査官：
- Jeffrey Marshall, MD
-
副調査官：
- Harvinder Singh, MD
-
副調査官：
- Agazi Gebreselassie, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Study participants will be selected from patients being cared for across the University of Maryland Medical System
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identification of tumor-associated host methylation signature
時間枠：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
時間枠：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
時間枠：5 years
|
The investigators will validate identified blood-based circulating methylation signatures in patients at high risk for developing pancreatic cancer. |
5 years
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。