Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer (OvCa). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Primary outcome measures
- Pathological diagnosis [Time frame: From enrollment to the end of surgery or biopsy at 1 weeks]
Secondary outcome measures (1)
- Progression [Time frame: From enrollment to the end of treatment at 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xiangya Hosipital of Central South University — Changsha
Identifiers
NCT: NCT06760923 · 2024040383