Endometrial CancerNCT06307886
Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator
An observational study of Endometrial Cancer, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator and lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Women only
- Adult, Older adult
Study population: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator
Who may be able to join
- patients suitable for laparoscopic surgery patients ages 18-75 patients diagnosed figo stage 1 and 2 endometrial cancer
Who cannot join
- patients not suitable for laparoscopic surgery patients diagnosed figo stage 3 and 4 endometrial cancer pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Training and research hospital
Istanbul
Süleyman Salman, Professor, +905059345470, sleymansalman@gmail.com
Havva Betül Bacak, Specialist, +905333610088, hbbacak90@gmail.com
About this study
Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator
- Conditions
- Endometrial Cancer
- Being tested
- Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator, lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulatorProcedure or surgery
patients who underwent laparoscopic hysterectomy with using uterine manipulator
lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulatorProcedure or surgery
patients who underwent laparoscopic hysterectomy without using uterine manipulator
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with endometrium cancer | Not described Receives: Procedure: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator; Procedure: lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
five year survival in patients diagnosed with endometrial cancer
Measured: 5 year
disease-free survival in patients diagnosed with endometrial cancer
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2028 (estimated)
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307886
- Sponsor's protocol ID
- GaziosmanpasaTREHSs
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator
- ClinicalTrials.gov ID
- NCT06307886
- Acronym / sponsor ID
- GaziosmanpasaTREHSs
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Mar 2024 (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.
Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with endometrium cancer | – | Procedure: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator, Procedure: lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator
Key inclusion criteria (1 listed)
- patients suitable for laparoscopic surgery patients ages 18-75 patients diagnosed figo stage 1 and 2 endometrial cancer
Key exclusion criteria (1 listed)
- patients not suitable for laparoscopic surgery patients diagnosed figo stage 3 and 4 endometrial cancer pregnant patients
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 |
|---|---|---|
| Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulatorpatients who underwent laparoscopic hysterectomy with using uterine manipulator | Procedure or surgery | patients diagnosed with endometrium cancer |
| lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulatorpatients who underwent laparoscopic hysterectomy without using uterine manipulator | Procedure or surgery | patients diagnosed with endometrium cancer |
Primary outcome
five year survival in patients diagnosed with endometrial cancer
Time frame: 5 year
disease-free survival in patients diagnosed with endometrial cancer
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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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.
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 Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Salman, Professor (+905059345470, sleymansalman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
five year survival in patients diagnosed with endometrial cancer (time frame: 5 year). The study lists 2 primary outcomes in all. 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 7 Jan 2025.