NCT03298100

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

December 27, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

September 27, 2017

Last Update Submit

December 26, 2018

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

  • Specificity and sensitivity of RHEA scoring mdel

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

    One year

Secondary Outcomes (1)

  • Variables to increase specificity and sensitivity of the score model

    One year

Study Arms (1)

Postmenopausal women

Other: Scoring model

Interventions

Scoring modelOTHER

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

Postmenopausal women

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 54678, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Asmaa F Kasem

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of obestetric and gynecology

Study Record Dates

First Submitted

September 27, 2017

First Posted

September 29, 2017

Study Start

September 26, 2017

Primary Completion

February 28, 2019

Study Completion

March 20, 2019

Last Updated

December 27, 2018

Record last verified: 2018-12

Locations

EG(1)