REM (Risk Of Endometrial Malignancy)

Campus Bio-Medico University of Rome

Status: Completed

Conditions: Endometrial Disease

Treatments: Other: Training set; Other: VERIFICATION SET

Study type: Interventional

Funder types: Other

Identifiers

NCT01830192

47/09 RA CBM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 741 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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741 participants in 2 patient groups

Training set

Other group

Description:

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

Treatment:

Other: Training set

VERIFICATION SET

Other group

Description:

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

Treatment:

Other: VERIFICATION SET