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Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection

12. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
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.
Andre navne:
  • Plasma cfDNA Methylation Test
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.
Diagnostisk test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
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.
Andre navne:
  • Plasma cfDNA Methylation Test

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic sensitivity
Tidsramme: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
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.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic specificity
Tidsramme: 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.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tongji Hospital

Samarbejdspartnere

The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Soochow University
The First Hospital of Jilin University
Women's Hospital School Of Medicine Zhejiang University
Renmin Hospital of Wuhan University
General Hospital of Ningxia Medical University
Shanghai First Maternity and Infant Hospital
Wuhan Central Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Xiangyang Central Hospital
The First Hospital of Lanzhou University, Gansu, China
Tongji Hospital affiliated to Tongji University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

30. december 2029

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TJ-OVMethy

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No individual participant data are planned to be shared at this time.

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