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Clinical Trials/NCT06760923
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

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:

  1. What is the difference in urinary protein composition between patients with ovarian cancer and those without it?
  2. Can these differences in urinary protein composition aid in the diagnosis of ovarian cancer?
  3. Are urinary protein markers associated with tumor burden in urine samples from patients with ovarian cancer?
  4. Can urinary protein markers be used for disease surveillance in ovarian cancer patients?
Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Xiangya Hospital of Central South University
Responsible Party
Sponsor

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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