NCT06760923
Recruiting
Not Applicable
Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression
Xiangya Hospital of Central South University1 site in 1 country240 target enrollmentJanuary 1, 2025
ConditionsOvarian Cancer (OvCa)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer (OvCa)
- Sponsor
- Xiangya Hospital of Central South University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Pathological diagnosis
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this observational study is to determine the urinary proteomic characteristics in women with and without ovarian cancer. The main questions it aims to answer are:
- What is the difference in urinary protein composition between patients with ovarian cancer and those without it?
- Can these differences in urinary protein composition aid in the diagnosis of ovarian cancer?
- Are urinary protein markers associated with tumor burden in urine samples from patients with ovarian cancer?
- Can urinary protein markers be used for disease surveillance in ovarian cancer patients?
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patients in the gynecological ward for surgical treatment.
- •Initial diagnosis of "pelvic mass" or "malignant ascites" may be considered as ovarian cancer; Or the initial diagnosis of "ovarian cyst", "hydrosalpinx", "uterine fibroids" or "uterine adenomyosis" are considered as gynecological non-malignant diseases.
- •Over 18 years of age.
- •Voluntary participation and signing of informed consent.
Exclusion Criteria
- •Study participants with a prior history of malignant tumors.
- •Study participants with prior chronic kidney disease or renal insufficiency.
- •Study participants who have received or are receiving treatment for primary disease.
- •Study participants whose pathological diagnosis was not clear.
- •Any patient should be excluded from the study if:
- •Study participants withdraw informed consent and request withdrawal.
- •Study participants were unable to provide a qualified urine sample.
- •There are situations in which the researcher considers it necessary to withdraw from the study.
Outcomes
Primary Outcomes
Pathological diagnosis
Time Frame: From enrollment to the end of surgery or biopsy at 1 weeks
The histological type of the disease is confirmed by surgery or biopsy
Secondary Outcomes
- Progression(From enrollment to the end of treatment at 6 months)
Study Sites (1)
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