Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

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?

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer (OvCa)

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Yu Zhang, PhD; Phone Number: +86 1511629658 +86 0731-89753999; Email: xyzhangyu@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hosipital of Central South University
      • Contact: Medical Ethics Committee of Xiangya Hospital; Phone Number: +86 0731-84327919; Email: xyyyllwyh@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Diagnosis undetermined; Patients who are initially diagnosed with conditions such as "pelvic mass" or "malignant ascites," which may suggest ovarian cancer, or those who are initially diagnosed with conditions such as "ovarian cyst," "hydrosalpinx," "uterine fibroids," or "adenomyosis," which are considered non-malignant gynecological diseases, and who have not yet undergone any surgery or treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological diagnosis	The histological type of the disease is confirmed by surgery or biopsy	From enrollment to the end of surgery or biopsy at 1 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: 2024040383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The affiliation has not approved to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No