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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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
Roberto Angioli, MD
Principal Investigator
Campus Biomedico University of Rome
Italy: Ethics Committee
47/09 RA CBM
NCT01830192
January 2010
December 2012
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