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REM (Risk Of Endometrial Malignancy) (REM)

Primary Purpose

Endometrial Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Training set
VERIFICATION SET
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Disease focused on measuring endometrial cancer, score, nomogram, ultrasound, HE4

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • campus bio-medico of Rome

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Training set

VERIFICATION SET

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 5, 2013
Last Updated
April 11, 2013
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT01830192
Brief Title
REM (Risk Of Endometrial Malignancy)
Acronym
REM
Official Title
REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Disease
Keywords
endometrial cancer, score, nomogram, ultrasound, HE4

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
741 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training set
Arm Type
Other
Arm Description
We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Arm Title
VERIFICATION SET
Arm Type
Other
Arm Description
We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Intervention Type
Other
Intervention Name(s)
Training set
Intervention Description
We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Intervention Type
Other
Intervention Name(s)
VERIFICATION SET
Intervention Description
We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Primary Outcome Measure Information:
Title
REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy.
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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
REM
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
REM
Description
We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged between 45 and 80 years; Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria; informed consent obtained from the patients. Exclusion Criteria: abnormal cardiac, haematological, renal, respiratory and/or hepatic functions; presence of a previous malignancy; presence of concomitant adnexal masses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Angioli, MD
Organizational Affiliation
Campus Biomedico University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
campus bio-medico of Rome
City
Rome
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

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REM (Risk Of Endometrial Malignancy)

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