REM (Risk Of Endometrial Malignancy) (REM)

April 11, 2013 updated by: Roberto Angioli, Campus Bio-Medico University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REM
Time Frame: 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.
2 years

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Principal Investigator: Roberto Angioli, MD, Campus Biomedico University of Rome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47/09 RA CBM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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