Endometrial CancerNCT05387460
Radiomics Based Multimodal Transvaginal Ultrasound Imaging in Endometrial Cancer
An observational study of Endometrial Cancer and Cervical Stromal Invasion, run by Tongji Hospital at 1 site in China.
Trial summary
Retrospectively collect preoperative transvaginal B-mode ultrasound (BMUS), color Doppler flow imaging (CDFI) and three-dimensional ultrasound (3D-US) images and clinical data in patients with non-endometrial cancer diseases and endometrial cancer confirmed by pathology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Cervical Stromal Invasion, Transvaginal Ultrasound
- What is being tested?
- radiomics
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Jul 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had Endometrial cancer or benign endometrial diseases and completed the transvaginal ultrasound examination before operation
Who may be able to join
- Patients diagnosed by operation and pathology
- Patients with preoperative transvaginal ultrasound images
Who cannot join
- Past history of gynecological malignant tumors
- Previous pelvic surgery or radiotherapy or chemotherapy
- Poor image quality
- Incomplete pathological or diagnosis report
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Radiomics Based on Multimodal Transvaginal Ultrasound Imaging in Predicting Endometrial Cancer and Cervical Stromal Invasion
Retrospectively collect preoperative transvaginal B-mode ultrasound (BMUS), color Doppler flow imaging (CDFI) and three-dimensional ultrasound (3D-US) images and clinical data in patients with non-endometrial cancer diseases and endometrial cancer confirmed by pathology. They were grouped as training set(Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology) and external validation set(Women's Hospital, School of Medicine, Zhejiang University) . Radiomics features were extracted from corresponding transvaginal ultrasound images. Then, the minimum redundancy maximum relevance (mRMR) algorithm and the least absolute shrinkage and selection operator (LASSO) regression were used to select the non- malignant or malignant status-related features and cervical stromal invasion (CSI) status or non-CSI status features and construct the transvaginal ultrasound radiomics score (Rad-score). Multivariate logistic regression was performed using the three radiomics score together with clinical data, and subsequently develop a nomogram to diagnosis endometrial cancer and CSI respectively. The performance of the nomogram was assessed by discrimination, calibration, and clinical usefulness in the training and external validation set.
Read the 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.
- Being tested
- radiomics
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiomicsDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Training cohort | The cohort of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology is a training cohort Intervention/treatment Receives: Diagnostic Test: radiomics | |
| validation cohort | The cohort of Women's Hospital, School of Medicine, Zhejiang University is a validation cohort Receives: Diagnostic Test: radiomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC value
Area under the receiver operating characteristic (ROC) curve (AUC）
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Diagnostic specificity
diagnosis specificity of intelligent ultrasound analysis
Measured: through study completion, an average of 1 year
Diagnostic sensitivity
diagnosis sensitivity of intelligent ultrasound analysis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Tongji 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387460
- Sponsor's protocol ID
- 2022-TJ-R-RBM
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics Based on Multimodal Transvaginal Ultrasound Imaging in Predicting Endometrial Cancer and Cervical Stromal Invasion
- ClinicalTrials.gov ID
- NCT05387460
- Acronym / sponsor ID
- 2022-TJ-R-RBM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 24 May 2022 (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.
Retrospectively collect preoperative transvaginal B-mode ultrasound (BMUS), color Doppler flow imaging (CDFI) and three-dimensional ultrasound (3D-US) images and clinical data in patients with non-endometrial cancer diseases and endometrial cancer confirmed by pathology. They were grouped as training set(Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology) and external validation set(Women's Hospital, School of Medicine, Zhejiang University) . Radiomics features were extracted from corresponding transvaginal ultrasound images. Then, the minimum redundancy maximum relevance (mRMR) algorithm and the least absolute shrinkage and selection operator (LASSO) regression were used to select the non- malignant or malignant status-related features and cervical stromal invasion (CSI) status or non-CSI status features and construct the transvaginal ultrasound radiomics score (Rad-score). Multivariate logistic regression was performed using the three radiomics score together with clinical data, and subsequently develop a nomogram to diagnosis endometrial cancer and CSI respectively. The performance of the nomogram was assessed by discrimination, calibration, and clinical usefulness in the training and external validation set.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Diagnostic Test: radiomicsThe cohort of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology is a training cohort Intervention/treatment |
| validation cohort | – | Diagnostic Test: radiomicsThe cohort of Women's Hospital, School of Medicine, Zhejiang University is a validation cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had Endometrial cancer or benign endometrial diseases and completed the transvaginal ultrasound examination before operation
Key inclusion criteria (2 listed)
- Patients diagnosed by operation and pathology
- Patients with preoperative transvaginal ultrasound images
Key exclusion criteria (4 listed)
- Past history of gynecological malignant tumors
- Previous pelvic surgery or radiotherapy or chemotherapy
- Poor image quality
- Incomplete pathological or diagnosis report
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 |
|---|---|---|
| radiomicsRadiomics 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. | Diagnostic test | Training cohort, validation cohort |
Primary outcome
AUC value
Time frame: through study completion, an average of 1 year
Area under the receiver operating characteristic (ROC) curve (AUC）
2 secondary outcomes
Diagnostic specificity
Time frame: through study completion, an average of 1 year
Diagnostic sensitivity
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometrial Cancer and Cervical Stromal Invasion, run by Tongji 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 2 inclusion and 4 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 24 May 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC value (time frame: through study completion, an average of 1 year). 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 24 May 2022.