REM (Risk Of Endometrial Malignancy)

Not Applicable

Completed

• Conditions: Endometrial Disease
• Interventions: Other: Training set; Other: VERIFICATION SET

• Registration Number: NCT01830192
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-11
• Last Update Submitted: 2013-04-11
• Study First Posted: 2013-04-12
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 741

Inclusion Criteria

1. aged between 45 and 80 years;
2. Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria;
3. informed consent obtained from the patients.

Exclusion Criteria

1. abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
2. presence of a previous malignancy;
3. presence of concomitant adnexal masses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training set	Training set	We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
VERIFICATION SET	VERIFICATION SET	We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative

Primary Outcome Measures

Name	Time	Method
REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy.	2 year	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.

Secondary Outcome Measures

Name	Time	Method
REM	2 years	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.

Trial Locations

Locations (1)

campus bio-medico of Rome; 🇮🇹 Rome, Italy