Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
12. Mai 2026 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
1000
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Qinglei Gao, Dr.
- Telefonnummer: +86-27-83662681
- E-Mail: qingleigao@hotmail.com
Studienorte
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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Kontakt:
- Qinglei Gao, Dr.
- Telefonnummer: +86-27-83662681
- E-Mail: qingleigao@hotmail.com
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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.
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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.
Andere Namen:
|
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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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Diagnostic sensitivity
Zeitfenster: 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
Zeitfenster: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection
Zeitfenster: 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.
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From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
|
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Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for early-stage ovarian cancer detection
Zeitfenster: 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
|
|
Detection performance of the blood-based cfDNA methylation panel in borderline ovarian tumors
Zeitfenster: 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.
|
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 precursor lesions or high-risk populations
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juli 2026
Primärer Abschluss (Geschätzt)
30. Juni 2029
Studienabschluss (Geschätzt)
30. Dezember 2029
Studienanmeldedaten
Zuerst eingereicht
12. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Mai 2026
Zuerst gepostet (Tatsächlich)
18. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Mai 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Erkrankungen des endokrinen Systems
- Pathologische Prozesse
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Genitalerkrankungen, weiblich
- Neoplasmen der endokrinen Drüse
- Eierstockerkrankungen
- Adnexerkrankungen
- Genitale Neubildungen, weiblich
- Gonadenstörungen
- Pathologische Zustände, Anzeichen und Symptome
- Eierstocktumoren
- Erkrankung
Andere Studien-ID-Nummern
- TJ-OVMethy
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
No individual participant data are planned to be shared at this time.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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