Ovarian Cancer (OvCa)NCT06760923
Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression
An observational study of Ovarian Cancer (OvCa), run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. What is the difference in urinary protein composition between patients with ovarian cancer and those without it? 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer (OvCa)
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hosipital of Central South University
Changsha, Hunan, 410008
Medical Ethics Committee of Xiangya Hospital, +86 0731-84327919, xyyyllwyh@126.com
About this study
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?
- Conditions
- Ovarian Cancer (OvCa)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological diagnosis
The histological type of the disease is confirmed by surgery or biopsy
Measured: From enrollment to the end of surgery or biopsy at 1 weeks
Secondary outcomes (1)
Progression
Patients with ovarian cancer who have recurrent disease after initial treatment with serological or imaging evidence
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer (OvCa)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760923
- Sponsor's protocol ID
- 2024040383
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The affiliation has not approved to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression
- ClinicalTrials.gov ID
- NCT06760923
- Acronym / sponsor ID
- 2024040383
- Conditions
- Ovarian Cancer (OvCa)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Study participants withdraw informed consent and request withdrawal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Progression
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No. The affiliation has not approved to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer (OvCa), run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, PhD (+86 0731-89753999 ext. +86 1511629658, xyzhangyu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological diagnosis (time frame: From enrollment to the end of surgery or biopsy at 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.