Endometrial DiseaseREMNCT01830192
REM (Risk Of Endometrial Malignancy)
A study testing Training set and VERIFICATION SET in people with Endometrial Disease, run by Campus Bio-Medico University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Endometrial Disease
- What is being tested?
- Training set and VERIFICATION SET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 741 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
- presence of a previous malignancy;
- presence of concomitant adnexal masses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate 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.
Read the 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.
- Conditions
- Endometrial Disease
- Being tested
- Training set, VERIFICATION SET
- Keywords
- endometrial cancer, score, nomogram, ultrasound, HE4
- Medical subject headings
- Uterine Diseases, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training setOther
We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
VERIFICATION SETOther
We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
| Study group | Role | What they receive |
|---|---|---|
| Training set | Other | We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative Receives: Other: Training set |
| VERIFICATION SET | Other | We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative Receives: Other: VERIFICATION SET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Angioli, Campus Bio-Medico University
- Investigators
- Roberto Angioli, MD, Principal investigator, Campus Biomedico University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830192
- Sponsor's protocol ID
- 47/09 RA CBM
- Acronym
- REM
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy
- ClinicalTrials.gov ID
- NCT01830192
- Acronym / sponsor ID
- REM / 47/09 RA CBM
- Conditions
- Endometrial Disease
- Keywords
- endometrial cancer, score, nomogram, ultrasound, HE4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training set | Other | Other: Training setWe evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative |
| VERIFICATION SET | Other | Other: VERIFICATION SETWe evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
- presence of a previous malignancy;
- presence of concomitant adnexal masses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training setWe evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative | Other | Training set |
| VERIFICATION SETWe evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative | Other | VERIFICATION SET |
Primary outcome
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.
1 secondary outcome
REM
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Angioli, MD principal investigator
Campus Biomedico University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training set and VERIFICATION SET in people with Endometrial Disease, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy. (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.