Endometrial CancerNCT02943811
Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer
An observational study of Endometrial Cancer, run by Università degli Studi dell'Insubria.
Trial summary
The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- UTERINE MANIPULATOR
- Type of treatment
- Medical device
- How many people
- 951 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2016
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women affected by early endometrial cancer
Who may be able to join
- Clinical stage I endometrial cancer
- Laparoscopic operation
Who cannot join
- post-operative oncologic follow-up < 12 months
- extra-uterine evidence of disease
About this study
Official title: Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study
The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer
Read the detailed description
The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.
Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.
- Conditions
- Endometrial Cancer
- Being tested
- UTERINE MANIPULATOR
- Keywords
- endometrial cancer, survival, 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.
UTERINE MANIPULATORDevice
Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus
| Study group | Role | What they receive |
|---|---|---|
| MANIPULATOR | Patients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator Receives: Device: UTERINE MANIPULATOR | |
| NO MANIPULATOR | Patients who were operated for endometrial cancer by laparoscopy without the use of a uterine manipulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease recurrence
Relapse of disease during follow-up
Measured: 4 years
Secondary outcomes (2)
disease specific survival
Kaplan Meyer curves and Log-rank test to explore disease-specific survival
Measured: 4 years
overall survival
Kaplan Meyer curves and Log-rank test to explore overall survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Università degli Studi dell'Insubria
- Investigators
- Stefano Uccella, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943811
- Sponsor's protocol ID
- 521
- Status last verified
- Nov 2016
- First submitted
- 22 Oct 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marcos-Sanmartin J, Lopez Fernandez JA, Sanchez-Paya J, Pinero-Sanchez OC, Roman-Sanchez MJ, Quijada-Cazorla MA, Candela-Hidalgo MA, Martinez-Escoriza JC. Does the Type of Surgical Approach and the Use of Uterine Manipulators Influence the Disease-Free Survival and Recurrence Rates in Early-Stage Endometrial Cancer? Int J Gynecol Cancer. 2016 Nov;26(9):1722-1726. doi: 10.1097/IGC.0000000000000808.
PubMed 27518143Tinelli R, Cicinelli E, Tinelli A, Bettocchi S, Angioni S, Litta P. Laparoscopic treatment of early-stage endometrial cancer with and without uterine manipulator: Our experience and review of literature. Surg Oncol. 2016 Jun;25(2):98-103. doi: 10.1016/j.suronc.2016.03.005. Epub 2016 Mar 23.
PubMed 27312035
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study
- ClinicalTrials.gov ID
- NCT02943811
- Acronym / sponsor ID
- 521
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, survival, uterine manipulator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Oct 2016 (estimated)
- 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.
The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer
Detailed description
The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.
Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MANIPULATOR | – | Device: UTERINE MANIPULATORPatients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator |
| NO MANIPULATOR | – | –Patients who were operated for endometrial cancer by laparoscopy without the use of a uterine manipulator |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women affected by early endometrial cancer
Key inclusion criteria (2 listed)
- Clinical stage I endometrial cancer
- Laparoscopic operation
Key exclusion criteria (2 listed)
- post-operative oncologic follow-up < 12 months
- extra-uterine evidence of disease
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 |
|---|---|---|
| UTERINE MANIPULATORPatients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus | Device | MANIPULATOR |
Primary outcome
Disease recurrence
Time frame: 4 years
Relapse of disease during follow-up
2 secondary outcomes
disease specific survival
Time frame: 4 years
overall survival
Time frame: 4 years
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 15 Nov 2016.
- Background: PubMed 27518143Marcos-Sanmartin J, Lopez Fernandez JA, Sanchez-Paya J, Pinero-Sanchez OC, Roman-Sanchez MJ, Quijada-Cazorla MA, Candela-Hidalgo MA, Martinez-Escoriza JC. Does the Type of Surgical Approach and the Use of Uterine Manipulators Influence the Disease-Free Survival and Recurrence Rates in Early-Stage Endometrial Cancer? Int J Gynecol Cancer. 2016 Nov;26(9):1722-1726. doi: 10.1097/IGC.0000000000000808.
- Background: PubMed 27312035Tinelli R, Cicinelli E, Tinelli A, Bettocchi S, Angioni S, Litta P. Laparoscopic treatment of early-stage endometrial cancer with and without uterine manipulator: Our experience and review of literature. Surg Oncol. 2016 Jun;25(2):98-103. doi: 10.1016/j.suronc.2016.03.005. Epub 2016 Mar 23.
- Individual participant dataSharing planned: No
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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.
Stefano Uccella principal investigator
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Università degli Studi dell'Insubria.
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 2 inclusion and 2 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Disease recurrence (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943811, which also lists 2 linked publications.
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 15 Nov 2016.