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REM (Risk Of Endometrial Malignancy) (REM)

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ClinicalTrials.gov Identifier: NCT01830192
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Roberto Angioli, Campus Bio-Medico University

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.

Condition or disease Intervention/treatment Phase
Endometrial Disease Other: Training set Other: VERIFICATION SET Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 741 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy
Study Start Date : January 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. REM [ Time Frame: 2 years ]
    We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830192


Locations
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Italy
campus bio-medico of Rome
Rome, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
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Principal Investigator: Roberto Angioli, MD Campus Biomedico University of Rome

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Responsible Party: Roberto Angioli, Professor, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01830192     History of Changes
Obsolete Identifiers: NCT01830179
Other Study ID Numbers: 47/09 RA CBM
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013
Keywords provided by Roberto Angioli, Campus Bio-Medico University:
endometrial cancer
score
nomogram
ultrasound
HE4
Additional relevant MeSH terms:
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Uterine Diseases
Genital Diseases, Female