REM (Risk Of Endometrial Malignancy)
REM
1 other identifier
interventional
741
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedApril 12, 2013
April 1, 2013
2.8 years
April 5, 2013
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
REM
2 years
Other Outcomes (1)
REM
2 years
Study Arms (2)
Training set
OTHERWe evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
VERIFICATION SET
OTHERWe evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
- presence of a previous malignancy;
- presence of concomitant adnexal masses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
campus bio-medico of Rome
Rome, 00128, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Angioli, MD
Campus Biomedico University of Rome
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 5, 2013
First Posted
April 12, 2013
Study Start
January 1, 2010
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
April 12, 2013
Record last verified: 2013-04