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Risk Scoring Model for Endometrial Cancer (Cohort)

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ClinicalTrials.gov Identifier: NCT03298100
Recruitment Status : Active, not recruiting
First Posted : September 29, 2017
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Asmaa Fahmy Kasem, Ain Shams University

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

Condition or disease Intervention/treatment
Oncology Other: Scoring model

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Risk Scoring Model for Prediction of Endometrial Cancer Among Symptomatic Postmenopausal Women(a Prospective Cohort Study).
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 20, 2019

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




Primary Outcome Measures :
  1. Specificity and sensitivity of RHEA scoring mdel [ Time Frame: One year ]
    Positive and negative productive values, specificity and sensitivity of RHEA scoring model


Secondary Outcome Measures :
  1. Variables to increase specificity and sensitivity of the score model [ Time Frame: One year ]
    Obesity, diabetes mellitus and family history



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298100


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt, 54678
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Asmaa F Kasem Ain Shams University

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Responsible Party: Asmaa Fahmy Kasem, Assistant lecturer of obestetric and gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03298100     History of Changes
Other Study ID Numbers: 3176af
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female