REM (Risk Of Endometrial Malignancy)

Endometrial Disease Clinical Trial

— REM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830192
• Other study ID #: 47/09 RA CBM
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: April 11, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01830179

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Endometrial Disease

Intervention

Other:
• Training set
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

Locations

Country	Name	City	State
Italy	campus bio-medico of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	REM	We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool	2 years	No
Primary	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	Yes
Secondary	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	No