REM (Risk Of Endometrial Malignancy)

Campus Bio-Medico University741 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

741

Conditions

Endometrial Disease

Interventions

Training setOTHER

We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative

VERIFICATION SETOTHER

We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

campus bio-medico of Rome

Rome, Italy

Outcomes

Primary Outcomes

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.

Time frame: 2 year

Secondary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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