Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
2026年5月12日 更新者：Qinglei Gao、Tongji Hospital
Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer
The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:
How well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?
Researchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.
Participants will:
Provide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis
調査の概要
状態
まだ募集していません
研究の種類
観察的
入学 (推定)
1000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Qinglei Gao, Dr.
- 電話番号：+86-27-83662681
- メール：qingleigao@hotmail.com
研究場所
-
-
Hubei
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Wuhan、Hubei、中国、430030
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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コンタクト：
- Qinglei Gao, Dr.
- 電話番号：+86-27-83662681
- メール：qingleigao@hotmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Women with complex ovarian or adnexal masses, including suspected ovarian-origin pelvic masses, who are planned to undergo first-time surgery or biopsy/pathologic sampling related to the current lesion at participating centers and are expected to have a postoperative pathologic diagnosis available as the reference standard.
The main analysis population consists of participants with pathologically confirmed early-stage invasive ovarian malignancies (FIGO 2014 stage IA-IIB) and participants with pathologically confirmed benign ovarian or adnexal diseases.
Participants with borderline ovarian tumors, advanced-stage invasive malignancies, and, where available, high-risk or precursor lesions may also be enrolled as exploratory cohorts.
説明
Inclusion Criteria:
- Female participants.
- Participants with an ovarian/adnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy/pathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.
- Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian/adnexal mass requiring differential diagnosis.
- An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian/adnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.
- Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.
- The participant or her legally authorized representative voluntarily signs written informed consent after being fully informed.
Exclusion Criteria:
- The participant has already received systemic anti-tumor treatment for the current ovarian/adnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.
- No pathologic diagnosis is ultimately obtained for the current ovarian/adnexal mass, or no analyzable pathologic conclusion can be established.
- Imaging findings at screening are highly typical of benign mature cystic teratoma.
- Ovarian cancer combined with another malignant tumor.
- There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Ovarian Cancer
Women with ovarian cancer who provide blood samples for cfDNA methylation testing.
Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis.
This cohort will be used to evaluate the sensitivity of the assay, including its performance in different histologic subtypes and early-stage disease.
|
A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection.
The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance.
他の名前：
|
|
Benign Gynecologic Diseases
Women with benign gynecologic diseases who provide blood samples for cfDNA methylation testing.
Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis.
This cohort will be used to evaluate the specificity of the assay.
|
A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection.
The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance.
他の名前：
|
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 |
|---|---|---|
|
Diagnostic sensitivity
時間枠：From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
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Diagnostic sensitivity of the blood-based cfDNA methylation panel, defined as the proportion of participants with ovarian cancer who test positive, using final clinical and/or pathological diagnosis as the reference standard.
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From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
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Diagnostic specificity
時間枠：From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
Diagnostic specificity of the blood-based cfDNA methylation panel, defined as the proportion of participants without ovarian cancer who test negative, using final clinical and/or pathological diagnosis as the reference standard.
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From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection
時間枠：From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for detecting early-stage ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
|
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
|
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for early-stage ovarian cancer detection
時間枠：From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for detecting early-stage ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
|
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
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Detection performance of the blood-based cfDNA methylation panel in borderline ovarian tumors
時間枠：From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
Detection performance of the blood-based cfDNA methylation panel in participants with borderline ovarian tumors, using final clinical and/or pathological diagnosis as the reference standard.
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From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
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Detection performance of the blood-based cfDNA methylation panel in precursor lesions or high-risk populations
時間枠：From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
|
Detection performance of the blood-based cfDNA methylation panel in participants with precursor lesions or in populations at high risk for ovarian cancer, using final clinical and/or pathological diagnosis or clinical classification as the reference standard.
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From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
|
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Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer
時間枠：From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
|
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Lofton-Day C, Model F, Devos T, Tetzner R, Distler J, Schuster M, Song X, Lesche R, Liebenberg V, Ebert M, Molnar B, Grutzmann R, Pilarsky C, Sledziewski A. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008 Feb;54(2):414-23. doi: 10.1373/clinchem.2007.095992. Epub 2007 Dec 18.
- Nie Y, Gao X, Cai X, Wu Z, Liang Q, Xu G, Liu N, Gao P, Deng J, Xu H, Shen Z, Cao C, Chen F, Zhang N, Song Y, Sun M, Liu C, Zhou G, Han W, Dou J, Xie H, Yao L, Liu Z, Ji G, Wang X, Zhao Q, Shang L, Fan D, Han X, Ren J, Liang H, Wang Z, Wang J, Wu Q, Yu J, Wu K; MAGIS Study Group. Combining methylated SEPTIN9 and RNF180 plasma markers for diagnosis and early detection of gastric cancer. Cancer Commun (Lond). 2023 Nov;43(11):1275-1279. doi: 10.1002/cac2.12478. Epub 2023 Aug 16. No abstract available.
- Liang W, Chen Z, Li C, Liu J, Tao J, Liu X, Zhao D, Yin W, Chen H, Cheng C, Yu F, Zhang C, Liu L, Tian H, Cai K, Liu X, Wang Z, Xu N, Dong Q, Chen L, Yang Y, Zhi X, Li H, Tu X, Cai X, Jiang Z, Ji H, Mo L, Wang J, Fan JB, He J. Accurate diagnosis of pulmonary nodules using a noninvasive DNA methylation test. J Clin Invest. 2021 May 17;131(10):e145973. doi: 10.1172/JCI145973.
- Xu RH, Wei W, Krawczyk M, Wang W, Luo H, Flagg K, Yi S, Shi W, Quan Q, Li K, Zheng L, Zhang H, Caughey BA, Zhao Q, Hou J, Zhang R, Xu Y, Cai H, Li G, Hou R, Zhong Z, Lin D, Fu X, Zhu J, Duan Y, Yu M, Ying B, Zhang W, Wang J, Zhang E, Zhang C, Li O, Guo R, Carter H, Zhu JK, Hao X, Zhang K. Circulating tumour DNA methylation markers for diagnosis and prognosis of hepatocellular carcinoma. Nat Mater. 2017 Nov;16(11):1155-1161. doi: 10.1038/nmat4997. Epub 2017 Oct 9.
- Zhang Q, Hu G, Yang Q, Dong R, Xie X, Ma D, Shen K, Kong B. A multiplex methylation-specific PCR assay for the detection of early-stage ovarian cancer using cell-free serum DNA. Gynecol Oncol. 2013 Jul;130(1):132-9. doi: 10.1016/j.ygyno.2013.04.048. Epub 2013 Apr 25.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2029年6月30日
研究の完了 (推定)
2029年12月30日
試験登録日
最初に提出
2026年5月12日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月12日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- TJ-OVMethy
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
No individual participant data are planned to be shared at this time.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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