Risk Scoring Model for Endometrial Cancer (Cohort)

December 26, 2018 updated by: Asmaa Fahmy Kasem, Ain Shams University

Assessment of Risk Scoring Model for Prediction of Endometrial Cancer Among Symptomatic Postmenopausal Women(a Prospective Cohort Study).

A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 54678
        • Ain shams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All postmenopausal women (who had their menses stopped for at least one year above age of 40) with vaginal bleeding.

Description

Inclusion Criteria:

- All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm

Exclusion Criteria:

  • all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Postmenopausal women
Other: Scoring model
Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity and sensitivity of RHEA scoring mdel
Time Frame: One year
Positive and negative productive values, specificity and sensitivity of RHEA scoring model
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variables to increase specificity and sensitivity of the score model
Time Frame: One year
Obesity, diabetes mellitus and family history
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Asmaa F Kasem, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2017

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

March 20, 2019

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

September 29, 2017

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3176af

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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