OncologyCohortNCT03298100
Risk Scoring Model for Endometrial Cancer
An observational study of Oncology, run by Ain Shams University at 1 site in Egypt.
Trial summary
A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Oncology
- What is being tested?
- Scoring model
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Sep 2017to 20 Mar 2019
- Phase
- Observational
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All postmenopausal women (who had their menses stopped for at least one year above age of 40) with vaginal bleeding.
Who may be able to join
- All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm
Who cannot join
- all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Oncology
- Being tested
- Scoring model
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoring modelOther
Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women | Not described Receives: Other: Scoring model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of RHEA scoring mdel
Positive and negative productive values, specificity and sensitivity of RHEA scoring model
Measured: One year
Secondary outcomes (1)
Variables to increase specificity and sensitivity of the score model
Obesity, diabetes mellitus and family history
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start26 Sep 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion20 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Fahmy Kasem, Ain Shams University
- Investigators
- Asmaa F Kasem, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298100
- Sponsor's protocol ID
- 3176af
- Acronym
- Cohort
- Status last verified
- Dec 2018
- First submitted
- 27 Sep 2017
- Last updated
- 27 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Risk Scoring Model for Prediction of Endometrial Cancer Among Symptomatic Postmenopausal Women(a Prospective Cohort Study).
- ClinicalTrials.gov ID
- NCT03298100
- Acronym / sponsor ID
- Cohort / 3176af
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 20 Mar 2019 (estimated)
- First posted
- 29 Sep 2017 (actual)
- 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.
A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women | – | Other: Scoring model |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All postmenopausal women (who had their menses stopped for at least one year above age of 40) with vaginal bleeding.
Key inclusion criteria (1 listed)
- All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm
Key exclusion criteria (1 listed)
- all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).
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 |
|---|---|---|
| Scoring modelDetermining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each | Other | Postmenopausal women |
Primary outcome
Specificity and sensitivity of RHEA scoring mdel
Time frame: One year
Positive and negative productive values, specificity and sensitivity of RHEA scoring model
1 secondary outcome
Variables to increase specificity and sensitivity of the score model
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Asmaa F Kasem principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Dec 2018. 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 Egypt. 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?
Results are not available in the source record.
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?
Specificity and sensitivity of RHEA scoring mdel (time frame: One 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 27 Dec 2018.