Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

Central South University

Status: Enrolling

Conditions: Ovarian Cancer (OvCa)

Study type: Observational

Funder types: Other

Identifiers

NCT06760923

2024040383

Details and patient eligibility

About

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?

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 1 patient group

Diagnosis undetermined

Description:

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.