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Completed

NCT Number: NCT01830192

REM (Risk Of Endometrial Malignancy)

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.

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Key information

Conditions

Endometrial Disease Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

45 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

campus bio-medico of Rome

Rome, 00128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training set

Other

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

VERIFICATION SET

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. REM

    Time frame: 2 years

    We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: REM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2013
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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