Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

NCT ID: NCT06760923

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Ovarian Cancer (OvCa)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiangya Hosipital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Zhang, PhD

Role: CONTACT

+86 0731-89753999 ext. +86 1511629658

Facility Contacts

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Medical Ethics Committee of Xiangya Hospital

Role: primary

+86 0731-84327919

Other Identifiers

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2024040383

Identifier Type: -

Identifier Source: org_study_id

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