Urinary Proteomic Assessment of Ovarian Malignancy and Di... | NCT06760923

Studies
Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression

NCT06760923

Sponsor

Xiangya Hospital of Central South University

Status

Recruiting

Last Update Posted

Jan 7, 2025Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Ovarian Cancer (OvCa)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Dec 27, 2024

First Submission Date that Met QC Criteria

Jan 6, 2025

First Posted Date

Jan 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2025

Last Update Posted Date

Jan 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Progression	Patients with ovarian cancer who have recurrent disease after initial treatment with serological or imaging evidence	From enrollment to the end of treatment at 6 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu Zhang, PhD	Contact	+86 0731-89753999	+86 1511629658	xyzhangyu@csu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiangya Hosipital of Central South University	Recruiting	Changsha	Hunan	410008	China

IPD Sharing Statement Module

Plan to Share IPD

Description

The affiliation has not approved to share individual participant data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

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