CClinicalTrials.gg
Status unknownNCT03298100CohortUpdated Dec 27, 2018

Risk Scoring Model for Endometrial Cancer

An observational study in Oncology, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-12-27.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
40 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Oncology
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Postmenopausal women

    Other: Scoring model

Interventions

  • OtherScoring model

    Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each

05

What researchers measure

Primary outcomes

  1. Specificity and sensitivity of RHEA scoring mdel

    Positive and negative productive values, specificity and sensitivity of RHEA scoring model

    Time frame: One year

Secondary outcomes

  1. Variables to increase specificity and sensitivity of the score model

    Obesity, diabetes mellitus and family history

    Time frame: One year

06

Study locations

1 site
  • Ain Shams University Maternity Hospital
    Cairo, 54678, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03298100
Lead sponsor
Ain Shams University
Responsible party
Asmaa Fahmy Kasem (Assistant lecturer of obestetric and gynecology, Ain Shams University) — Principal investigator
First posted
Sep 29, 2017
Start date
Sep 26, 2017
Primary completion
Feb 28, 2019 (estimated)
Completion
Mar 20, 2019 (estimated)
Last update
Dec 27, 2018

Study contacts

Asmaa F Kasem
principal investigator · Ain Shams University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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