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

45 Years
80 Years
Not Enrolling
Endometrial Disease

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy.

Outcome Description:

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.

Outcome Time Frame:

2 year

Safety Issue:


Principal Investigator

Roberto Angioli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Campus Biomedico University of Rome


Italy: Ethics Committee

Study ID:

47/09 RA CBM



Start Date:

January 2010

Completion Date:

December 2012

Related Keywords:

  • Endometrial Disease
  • endometrial cancer
  • score
  • nomogram
  • ultrasound
  • HE4
  • Neoplasms
  • Adenoma
  • Uterine Diseases