Endometrial Polyp.NCT01203176
Incidence of Malignant and Premalignant Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
A study testing Hysteroscopic polypectomy in people with Endometrial Polyp. and Malignant and Pre-malignant Changes in the Polyp, run by Arie Lissak, MD at 1 site in Israel.
Trial summary
The prevalence of endometrial polyp is 24% in the general population but is much higher in postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 2 to 10% in menopausal women. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Polyp., Malignant and Pre-malignant Changes in the Polyp
- What is being tested?
- Hysteroscopic polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Aug 2014
- Phase
- Interventional
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal symptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp.
- Postmenopausal asymptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp
- Women who can read and understand and sign consent form
- Women between 18 and 80 years of age.
- ASA (American Society of Anesthesiologist) physical status grade 1-3
Who cannot join
- Histological Evidence of endometrial malignancy
- Asymptomatic woman with endometrial polyps smaller than 4 mm with no risk factors that fulfills one of the following conditions:
- Immune depressed or terminal illness.
- Women under anticoagulant treatment that its discontinuation, as a precondition for medical surgical intervention, could endanger their health.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa
Arie Lissak, MD, 97248250637, lissak_arie@clalit.org.il
Arie Lissak, MD
About this study
Official title: Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
The prevalence of endometrial polyp is 24% in the general population but is much higher in postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 2 to 10% in menopausal women.
Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care, same goes for asymptomatic women with risk factors for endometrial malignancy, however treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is disputable.
In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, the investigators are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp
Read the detailed description
Endometrial polyp is a common finding in postmenopausal women. The prevalence of endometrial polyps is 24% in the general population, but is much higher in postmenopausal in compare to premenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 0.5 to 4.8% in the general population and from 2 to 10% in menopausal women. There is an increased risk for malignant or pre-malignant polyp in postmenopausal women and it correlates with age.
Removal of endometrial polyps in postmenopausal symptomatic (bleeding, pain, vaginal discharge) women is the standard of care, same goes for asymptomatic women with risk factors (e.g., hypertension, history of breast, ovary, endometrial or colon cancer, Tamoxifen or estrogen treatment, over-weight, no ovulation, previous endometrial hyperplasia) due to a relatively high risk for malignancy. However treatment of asymptomatic postmenopausal women endometrial polyp but no risk factors is disputable.
Article published in the recent years introduced a similar rate of involvement of malignant and pre-malignant changes in polyps removed from post-menopausal women, symptomatic and asymptomatic (3.2% versus 3.9%, respectively).
In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, and in light of the fact that all major studies in this field were made retrospectively, we are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp
- Being tested
- Hysteroscopic polypectomy
- Keywords
- Endometrial polyp, Endometrial carcinoma, Endometrial hyperplasia, Postmenopausal symptomatic women, Postmenopausal asymptomatic women
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic polypectomyProcedure or surgery
Hysteroscopy is a well established minimally invasive surgery method for diagnostic and intervention operations inside the uterine cavity. Using this method one can observe the endometrium and remove polyps.
| Study group | Role | What they receive |
|---|---|---|
| Post-menopausal symptomatic women | Active comparator | Not described Receives: Procedure: Hysteroscopic polypectomy |
| Post-menopausal asymptomatic women | Experimental | Not described Receives: Procedure: Hysteroscopic polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
Measured: 3 years
Sonographic characteristics and histo-pathologic measures of endometrial polyp
Measured: 3 years
Secondary outcomes (2)
Rate of complications during or around the operation
Measured: 3 years
Correlation between the sonographic characteristics and histopathological findings
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Polyp.Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arie Lissak, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arie Lissak, MD, Carmel Medical Center
- Investigators
- Arie Lissak, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203176
- Sponsor's protocol ID
- CMC-08-0073 CTIL
- Status last verified
- Dec 2013
- First submitted
- 31 Aug 2010
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Malignant and Pre-malignant Findings in Endometrial Polyp in Asymptomatic and Symptomatic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01203176
- Acronym / sponsor ID
- CMC-08-0073 CTIL
- Keywords
- Endometrial polyp, Endometrial carcinoma, Endometrial hyperplasia, Postmenopausal symptomatic women, Postmenopausal asymptomatic women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Arie Lissak, MDUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 16 Sep 2010 (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 prevalence of endometrial polyp is 24% in the general population but is much higher in postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 2 to 10% in menopausal women.
Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care, same goes for asymptomatic women with risk factors for endometrial malignancy, however treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is disputable.
In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, the investigators are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp
Detailed description
Endometrial polyp is a common finding in postmenopausal women. The prevalence of endometrial polyps is 24% in the general population, but is much higher in postmenopausal in compare to premenopausal women. The incidence of malignant or pre-malignant findings in endometrial polyps ranges from 0.5 to 4.8% in the general population and from 2 to 10% in menopausal women. There is an increased risk for malignant or pre-malignant polyp in postmenopausal women and it correlates with age.
Removal of endometrial polyps in postmenopausal symptomatic (bleeding, pain, vaginal discharge) women is the standard of care, same goes for asymptomatic women with risk factors (e.g., hypertension, history of breast, ovary, endometrial or colon cancer, Tamoxifen or estrogen treatment, over-weight, no ovulation, previous endometrial hyperplasia) due to a relatively high risk for malignancy. However treatment of asymptomatic postmenopausal women endometrial polyp but no risk factors is disputable.
Article published in the recent years introduced a similar rate of involvement of malignant and pre-malignant changes in polyps removed from post-menopausal women, symptomatic and asymptomatic (3.2% versus 3.9%, respectively).
In light of ambiguity in literature regarding the rate of malignant and pre-malignant findings in polyps in asymptomatic post-menopausal women, and in light of the fact that all major studies in this field were made retrospectively, we are asking to conduct a prospective study in order to evaluate and compare the incidence of malignant and pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial polyp
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-menopausal symptomatic women | Active comparator | Procedure: Hysteroscopic polypectomy |
| Post-menopausal asymptomatic women | Experimental | Procedure: Hysteroscopic polypectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal symptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp.
- Postmenopausal asymptomatic women with Ultrasonographic or other imaging findings that correlates with endometrial polyp
- Women who can read and understand and sign consent form
- Women between 18 and 80 years of age.
- ASA (American Society of Anesthesiologist) physical status grade 1-3
Key exclusion criteria (4 listed)
- Histological Evidence of endometrial malignancy
- Asymptomatic woman with endometrial polyps smaller than 4 mm with no risk factors that fulfills one of the following conditions:
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 |
|---|---|---|
| Hysteroscopic polypectomyHysteroscopy is a well established minimally invasive surgery method for diagnostic and intervention operations inside the uterine cavity. Using this method one can observe the endometrium and remove polyps. | Procedure or surgery | Post-menopausal asymptomatic women, Post-menopausal symptomatic women |
Primary outcome
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women
Time frame: 3 years
Sonographic characteristics and histo-pathologic measures of endometrial polyp
Time frame: 3 years
2 secondary outcomes
Rate of complications during or around the operation
Time frame: 3 years
Correlation between the sonographic characteristics and histopathological findings
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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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.
Arie Lissak, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic polypectomy in people with Endometrial Polyp. and Malignant and Pre-malignant Changes in the Polyp, run by Arie Lissak, MD at 1 site in Israel.
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 5 inclusion and 4 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 3 Dec 2013. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of malignant and pre-malignant changes in polyps removed from symptomatic and asymptomatic post-menopausal women (time frame: 3 years). 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 3 Dec 2013.