Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorTongji Hospital
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tongji Hospital
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Xiangyang Central Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
Renmin Hospital of Wuhan University
Collaborator
General Hospital of Ningxia Medical University
Collaborator
Wuhan Central Hospital
Collaborator
The First Hospital of Lanzhou University, Gansu, China
Collaborator
Tongji Hospital affiliated to Tongji University
Collaborator
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Collaborator
Source ClinicalTrials.gov