Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

NCT06760923 | Recruiting

• 1 other identifier: 2024040383
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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. 1.What is the difference in urinary protein composition between patients with ovarian cancer and those without it?
2. 2.Can these differences in urinary protein composition aid in the diagnosis of ovarian cancer?
3. 3.Are urinary protein markers associated with tumor burden in urine samples from patients with ovarian cancer?
4. 4.Can urinary protein markers be used for disease surveillance in ovarian cancer patients?

Conditions

Ovarian Cancer (OvCa)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression

  From enrollment to the end of treatment at 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hosipital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Yu Zhang, PhD

CONTACT

+86 0731-89753999; xyzhangyu@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 7, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)