REM (Risk Of Endometrial Malignancy)

NCT ID: NCT01830192

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 741 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Endometrial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Training set

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

Group Type: OTHER

Training set

Intervention Type: OTHER

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

VERIFICATION SET

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

Group Type: OTHER

VERIFICATION SET

Intervention Type: OTHER

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

Interventions

Training set

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

Intervention Type: OTHER

VERIFICATION SET

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Angioli

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Angioli, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Biomedico University of Rome

Locations

campus bio-medico of Rome

Rome, , Italy

Countries

Italy

Other Identifiers

47/09 RA CBM

Identifier Type: -

Identifier Source: org_study_id

NCT01830179

Identifier Type: -

Identifier Source: nct_alias