Early Detection of Cancer, Ovarian Cancer, Ovarian Neoplasms
Conditions
Keywords
Ovarian Cancer, Ovarian Neoplasms, cfDNA Methylation, Cell-Free DNA, DNA Methylation, Liquid Biopsy, Blood-Based Assay, Early Detection, Biomarker, Early Diagnosis, Diagnostic Performance, Ovarian Tumor
Brief summary
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
Interventions
DIAGNOSTIC_TESTBlood-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.
Sponsors
Tongji Hospital
Women's Hospital School Of Medicine Zhejiang University
The Affiliated Hospital of Qingdao University
Shanghai First Maternity and Infant Hospital
The First Affiliated Hospital of Soochow University
Xiangyang Central Hospital
The First Hospital of Jilin University
Renmin Hospital of Wuhan University
General Hospital of Ningxia Medical University
Wuhan Central Hospital
The First Hospital of Lanzhou University, Gansu, China
Tongji Hospital affiliated to Tongji University
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity | 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. |
| Diagnostic specificity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection | 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. |
| Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for early-stage ovarian cancer detection | 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. |
| Detection performance of the blood-based cfDNA methylation panel in borderline ovarian tumors | 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. |
| Detection performance of the blood-based cfDNA methylation panel in precursor lesions or high-risk populations | 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. |
| Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer | 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. |
Countries
China
Contacts
CONTACTQinglei Gao, Dr.
Outcome results
None listed