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?

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Key information

Conditions

Ovarian Cancer (OvCa) Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Xiangya Hosipital of Central South University

Changsha, Hunan, 410008, China

Location status: Recruiting

Location contact

Medical Ethics Committee of Xiangya Hospital

CONTACT

[email protected]

+86 0731-84327919

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Zhang, PhD

CONTACT

[email protected]

+86 0731-89753999 ext. +86 1511629658

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jan 7, 2025
Registry last updated: Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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