- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05387460
Radiomics Based Multimodal Transvaginal Ultrasound Imaging in Endometrial Cancer
Radiomics Based on Multimodal Transvaginal Ultrasound Imaging in Predicting Endometrial Cancer and Cervical Stromal Invasion
Study Overview
Status
Intervention / Treatment
Detailed Description
Endometrial Cancer is the second most common gynecological cancer in China and the first in Western countries. The common clinical symptom of endometrial cancer is vaginal bleeding, which occurs in about 10% of postmenopausal women. Most patients with postmenopausal vaginal bleeding are diagnosed with benign diseases, and less than 10% of patients are diagnosed with endometrial cancer. Early diagnosis is crucial for the prognosis of patients with endometrial cancer. The 5-year survival rate of patients with endometrial cancer which lesions localized to the uterus is about 95%, while the survival rate of patients with regional and distant metastasis is reduced to less than 70% and 20%.
Surgery is the main treatment of endometrial cancer. CSI is one of the main criteria for determining the follow-up treatment. According to NCCN guidelines, Total Hysterectomy and Bilateral Salpingo-Oophorectomy (THBSO) are standard treatments for patients with endometrioid carcinoma without CSI. While extensive hysterectomy or surgery after radiotherapy is appropriate for patients with CSI. Therefore, accurate assessment of CSI status in patients with EC before operation is important for the formulation of accurate surgical strategies.
Endometrial biopsy has been considered the gold standard for assessing endometrial cancer. However, it is limited because of increased cost, sample errors, related complications such as pain, bleeding, inability to evaluate the extent of tumor invasion and easy to cause tumor spread. CT/MR are alternative ways with high cost and complications. Transvaginal ultrasound examination is considered as the first imaging investigation for endometrial cancer. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma indicate that transvaginal ultrasound can be used instead of magnetic resonance imaging to detect cervical stromal infiltration under the operation of experienced doctors. Improving the performance of ultrasonic diagnosis is significant for how to choose the follow-up treatment and reduce the cost and risk of overtreatment.
Radiomics refers to high-throughput mining of quantitative image features from medical imaging. Radiomics derived data, when combined with other pertinent clinicopathological features, can produce accurate and robust evidence-based decision-making systems. Multimodal radiomics can provide more imaging feature information than single modal radiomics, which showed better diagnostic performance in previous study of kinds of cancer diseases.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed by operation and pathology
- Patients with preoperative transvaginal ultrasound images
Exclusion Criteria:
- Past history of gynecological malignant tumors
- Previous pelvic surgery or radiotherapy or chemotherapy
- Poor image quality
- Incomplete pathological or diagnosis report
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Training cohort
The cohort of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology is a training cohort Intervention/treatment
|
Radiomics refers to high-throughput mining of quantitative image features from medical imaging.
Radiomics derived data, when combined with other pertinent clinicopathological features, can produce accurate and robust evidence-based decision-making systems.
Multimodal radiomics can provide more imaging feature information than single modal radiomics, which showed better diagnostic performance in previous study of kinds of cancer diseases.
|
validation cohort
The cohort of Women's Hospital, School of Medicine, Zhejiang University is a validation cohort
|
Radiomics refers to high-throughput mining of quantitative image features from medical imaging.
Radiomics derived data, when combined with other pertinent clinicopathological features, can produce accurate and robust evidence-based decision-making systems.
Multimodal radiomics can provide more imaging feature information than single modal radiomics, which showed better diagnostic performance in previous study of kinds of cancer diseases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC value
Time Frame: through study completion, an average of 1 year
|
Area under the receiver operating characteristic (ROC) curve (AUC)
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic specificity
Time Frame: through study completion, an average of 1 year
|
diagnosis specificity of intelligent ultrasound analysis
|
through study completion, an average of 1 year
|
Diagnostic sensitivity
Time Frame: through study completion, an average of 1 year
|
diagnosis sensitivity of intelligent ultrasound analysis
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-TJ-R-RBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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