Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

Recruiting

• Conditions: Ovarian Cancer (OvCa)

• Registration Number: NCT06760923
• Lead Sponsor: Xiangya Hospital of Central South University

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological diagnosis	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 Outcome Measures

Name	Time	Method
Progression	From enrollment to the end of treatment at 6 months	Patients with ovarian cancer who have recurrent disease after initial treatment with serological or imaging evidence

Trial Locations

Locations (1)

Xiangya Hosipital of Central South University; 🇨🇳 Changsha, Hunan, China