Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

12. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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 navn:
  • 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 navn:
  • Plasma cfDNA Methylation Test

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tongji Hospital

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. juni 2029

Studiet fullført (Antatt)

30. desember 2029

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TJ-OVMethy

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere