Endometrial CancerNCT04120649
Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
An observational study of Endometrial Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in Western countries. Histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 May 2020to 1 Aug 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who having endometrial carcinoma
Who may be able to join
- Not virgin
- Not having congenital anomalies
- Early stage
- Body mass index less than 35
Who cannot join
- virgin
- advanced stage
- sever infection especially in the pelvis
- lymphadenopathy for any cause
- lymphadenectomy for any cause
- BMI more than 35
- Synchronous malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
Endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in Western countries. Histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. Systematic lymphadenectomy has recently been questioned for stage I disease based on the results from two randomized trials
- Conditions
- Endometrial Cancer
- Being tested
- hysterectomy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterectomyProcedure or surgery
total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings
| Study group | Role | What they receive |
|---|---|---|
| endomterial cancer | All patients visiting the clinic at Women Health Hospital who having endometrial carcinoma with their diagnosis based on investigations (tumor marker ) , imaging, histopathology will have surgical staging consisted of total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings Receives: Procedure: hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the validity of Mayo criteria risk stratification model
risk stratification model for prediction of lymph node involvement in women with endometrial carcinoma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start18 May 2020
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120649
- Sponsor's protocol ID
- RSMLI
- Status last verified
- Aug 2022
- First submitted
- 6 Oct 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT04120649
- Acronym / sponsor ID
- RSMLI
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 9 Oct 2019 (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.
Endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in Western countries. Histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. Systematic lymphadenectomy has recently been questioned for stage I disease based on the results from two randomized trials
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endomterial cancer | – | Procedure: hysterectomyAll patients visiting the clinic at Women Health Hospital who having endometrial carcinoma with their diagnosis based on investigations (tumor marker ) , imaging, histopathology will have surgical staging consisted of total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who having endometrial carcinoma
Key inclusion criteria (4 listed)
- Not virgin
- Not having congenital anomalies
- Early stage
- Body mass index less than 35
Key exclusion criteria (7 listed)
- virgin
- advanced stage
- sever infection especially in the pelvis
- lymphadenopathy for any cause
- lymphadenectomy for any cause
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 |
|---|---|---|
| hysterectomytotal hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings | Procedure or surgery | endomterial cancer |
Primary outcome
the validity of Mayo criteria risk stratification model
Time frame: 3 months
risk stratification model for prediction of lymph node involvement in women with endometrial carcinoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometrial Cancer, run by Assiut 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 25 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the validity of Mayo criteria risk stratification model (time frame: 3 months). 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 25 Aug 2022.