REM (Risk Of Endometrial Malignancy)

Study Overview
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Brief Summary
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The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.

Detailed Description
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Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.

Official Title
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REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy

Conditions
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Endometrial Disease

Intervention / Treatment
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* Other: Training set
* Other: VERIFICATION SET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 45 and 80 years; Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria; informed consent obtained from the patients. Exclusion Criteria: abnormal cardiac, haematological, renal, respiratory and/or hepatic functions; presence of a previous malignancy; presence of concomitant adnexal masses.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Training set<br>We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative | Other: Training set<br>* We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative<br>|
| Other: VERIFICATION SET<br>We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative | Other: VERIFICATION SET<br>* We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy. | We select patients affected by endometrial cancer and benign endometrial disease. Preoperative they underwent to pelvic ultrasound, CA125 and HE4 dosage and anamnesis. They will be considered as training group to obtaine the probability of endometrial malignancy based on HE4, ultrasound features and symptoms. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REM | We select a verification set, composed by endometrial cancer disease and benign endometrial pathologies patients. In this set we apply the risk of endometrial cancer tool, obtained in the training set, in order to verify the sensitivity, specificity and reproducibility. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, score, nomogram, ultrasound, HE4