Epithelial Ovarian CancerNCT06085456
Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study
An observational study of Epithelial Ovarian Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to identify the demographic and sociological characteristics of epithelial ovarian cancer in a cohort, identify the risk factors of epithelial ovarian cancer, effectively identify the high-risk population of epithelial ovarian cancer in the population, implement standardized health… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Hematologic features
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed as primary epithelial ovarian cancer or patients diagnosed as benign gynecological diseases including ovarian cysts, uterine fibroids, and uterine prolapse
Who may be able to join
- Patients were diagnosed as primary epithelial ovarian cancer with definite pathological stage and grade and underwent preoperative PET/CT examination, or patients diagnosed as benign gynecological diseases including ovarian cysts, uterine fibroids, and uterine prolapse.
- age between 18 to 80 years old;
- complete preoperative blood routine test results, blood biochemical indicators, and tumor markers;
Who cannot join
- complicated with acute or chronic genital tract infectious diseases;
- patients with diagnosed tumors other than ovarian cancer;
- complicated with severe systemic diseases;
- pregnant or lactating women;
- patients diagnosed with recurrent epithelial ovarian cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Sijia Gu, 86+15021845201, gusijia47@163.com
About this study
The purpose of this study is to identify the demographic and sociological characteristics of epithelial ovarian cancer in a cohort, identify the risk factors of epithelial ovarian cancer, effectively identify the high-risk population of epithelial ovarian cancer in the population, implement standardized health management, and clarify the effect of standardized health management on the incidence and prognosis of epithelial ovarian cancer. It can also provide a case control population for the clinical cohort of epithelial ovarian cancer to benefit the majority of postoperative patients.
Read the detailed description
- The clinical characteristics, preoperative hematological parameters of patients with epithelial ovarian cancer and patients with benign gynecological diseases, and the pathological stage, grade and features extracted by PET/CT images of patients with epithelial ovarian cancer were recorded.
- Patients from Renji Hospital were divided into training group and test group at a ratio of 7:3, and patients from Shanghai First Maternity and Infant Hospital were used as external validation group.
- The training group was used to establish the diagnosis and prognosis prediction model of epithelial ovarian cancer, and the test group and the external validation group were used to verify the model, and the area under the ROC curve, accuracy, specificity, and sensitivity were used to evaluate the effect of the model.
- For machine learning models, SHAP and LIME algorithms were used for model interpretation.
- Unsupervised clustering algorithm was used to distinguish the subgroups of epithelial ovarian cancer patients, and KM was used to analyze the overall survival (OS) and progression-free survival (PFS) to predict the survival and recurrence of the subgroups. Overall survival (OS) was defined as the time from the first diagnosis of epithelial ovarian cancer to the confirmation of death or the end of follow-up. Progression-free survival (PFS) was defined as the time from the first diagnosis of epithelial ovarian cancer to the confirmation of disease progression or the end of follow-up.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Hematologic features
- Keywords
- Epithelial Ovarian Cancer, Diagnosis, Prognosis
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematologic featuresDiagnostic test
Hematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery
| Study group | Role | What they receive |
|---|---|---|
| EOC group | Patients diagnosed with epithelial ovarian cancer Receives: Diagnostic Test: Hematologic features | |
| Control group | Patients diagnosed with benign gynecological diseases, including ovarian cysts, uterine fibroids and uterine prolapse. Receives: Diagnostic Test: Hematologic features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diagnosed patients
Patients were diagnosed with epithelial ovarian cancer or benign gynecological diseases (including ovarian cysts, uterine fibroids, and uterine prolapse). The blood characteristics of patients with epithelial ovarian cancer and patients with benign gynecological diseases (including ovarian cysts, uterine fibroids, and uterine prolapse) were compared to observe the performance of the study model in predicting disease diagnosis
Measured: one month after surgery
Secondary outcomes (2)
Overall survival
The time from the first surgical or biopsy diagnosis of epithelial ovarian cancer to confirmed death or the end of follow-up
Measured: up to 5 years
Progression-free survival
The time from the first surgical or needle biopsy diagnosis of epithelial ovarian cancer to the confirmation of disease progression or the end of follow-up
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Sep 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimin Zhao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085456
- Sponsor's protocol ID
- IIT-2023-0202
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06085456
- Acronym / sponsor ID
- IIT-2023-0202
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Epithelial Ovarian Cancer, Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Oct 2023 (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 purpose of this study is to identify the demographic and sociological characteristics of epithelial ovarian cancer in a cohort, identify the risk factors of epithelial ovarian cancer, effectively identify the high-risk population of epithelial ovarian cancer in the population, implement standardized health management, and clarify the effect of standardized health management on the incidence and prognosis of epithelial ovarian cancer. It can also provide a case control population for the clinical cohort of epithelial ovarian cancer to benefit the majority of postoperative patients.
Detailed description
- The clinical characteristics, preoperative hematological parameters of patients with epithelial ovarian cancer and patients with benign gynecological diseases, and the pathological stage, grade and features extracted by PET/CT images of patients with epithelial ovarian cancer were recorded.
- Patients from Renji Hospital were divided into training group and test group at a ratio of 7:3, and patients from Shanghai First Maternity and Infant Hospital were used as external validation group.
- The training group was used to establish the diagnosis and prognosis prediction model of epithelial ovarian cancer, and the test group and the external validation group were used to verify the model, and the area under the ROC curve, accuracy, specificity, and sensitivity were used to evaluate the effect of the model.
- For machine learning models, SHAP and LIME algorithms were used for model interpretation.
- Unsupervised clustering algorithm was used to distinguish the subgroups of epithelial ovarian cancer patients, and KM was used to analyze the overall survival (OS) and progression-free survival (PFS) to predict the survival and recurrence of the subgroups. Overall survival (OS) was defined as the time from the first diagnosis of epithelial ovarian cancer to the confirmation of death or the end of follow-up. Progression-free survival (PFS) was defined as the time from the first diagnosis of epithelial ovarian cancer to the confirmation of disease progression or the end of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOC group | – | Diagnostic Test: Hematologic featuresPatients diagnosed with epithelial ovarian cancer |
| Control group | – | Diagnostic Test: Hematologic featuresPatients diagnosed with benign gynecological diseases, including ovarian cysts, uterine fibroids and uterine prolapse. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as primary epithelial ovarian cancer or patients diagnosed as benign gynecological diseases including ovarian cysts, uterine fibroids, and uterine prolapse
Key inclusion criteria (3 listed)
- Patients were diagnosed as primary epithelial ovarian cancer with definite pathological stage and grade and underwent preoperative PET/CT examination, or patients diagnosed as benign gynecological diseases including ovarian cysts, uterine fibroids, and uterine prolapse.
- age between 18 to 80 years old;
- complete preoperative blood routine test results, blood biochemical indicators, and tumor markers;
Key exclusion criteria (5 listed)
- complicated with acute or chronic genital tract infectious diseases;
- patients with diagnosed tumors other than ovarian cancer;
- complicated with severe systemic diseases;
- pregnant or lactating women;
- patients diagnosed with recurrent epithelial ovarian cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematologic featuresHematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery | Diagnostic test | Control group, EOC group |
Primary outcome
Number of diagnosed patients
Time frame: one month after surgery
Patients were diagnosed with epithelial ovarian cancer or benign gynecological diseases (including ovarian cysts, uterine fibroids, and uterine prolapse). The blood characteristics of patients with epithelial ovarian cancer and patients with benign gynecological diseases (including ovarian cysts, uterine fibroids, and uterine prolapse) were compared to observe the performance of the study model in predicting disease diagnosis
2 secondary outcomes
Overall survival
Time frame: up to 5 years
Progression-free survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aimin Zhao, MD principal investigator
RenJi Hospital
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 Epithelial Ovarian Cancer, run by RenJi Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sijia Gu (86+15021845201, gusijia47@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of diagnosed patients (time frame: one month after surgery). 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 17 Oct 2023.