REM (Risk Of Endometrial Malignancy) (REM)

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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Disease
• Intervention / Treatment: Other: Training set; Other: VERIFICATION SET

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 Type: Interventional
• Enrollment (Actual): 741
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00128
    • Campus Bio-Medico of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Training set; We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative	Other: Training set; We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Other: VERIFICATION SET; We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative	Other: VERIFICATION SET; We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Roberto Angioli, MD, Campus Biomedico University of Rome

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Estimate): April 12, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: ultrasound; endometrial cancer; HE4; nomogram; score
• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: 47/09 RA CBM