REM (Risk Of Endometrial Malignancy)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01830192

Acronym

REM

Enrollment

741

Registered

2013-04-12

Start date

2010-01-31

Completion date

2012-12-31

Last updated

2013-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Disease

Keywords

endometrial cancer, score, nomogram, ultrasound, HE4

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.

Interventions

OTHERTraining set

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

OTHERVERIFICATION SET

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
REM	2 years	We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026