- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247923
Endometrial Polyps: Pathophysiology and Clinical Consequences
Endometrial Polyps. Pathophysiology and Clinical Consequences.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Part 1: New diagnostic methods for the prediction of malignancy in endometrial polyps: A prospective pilot study.
Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies from the endometrium and by Doppler ultrasound combined with IV contrast. We hope to find specific characteristics with new vessel formation in the endometrial polyp, which can play a role in the prognostic evaluation regarding the risk for cancer development. We will compare women with endometrial polyps and women with endometrial cancer to see if these methods of angiogenesis evaluation may be useful in separating benign polyps from premalignant and malignant polyps.
Study Part 2: The natural history of endometrial polyps. A prospective randomised study of patients with endometrial polyps.
Blood loss during menstruation is documented with the help of a standardized form (PBAC). The patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months of observation. A new registration of blood loss during menstruation is performed by patients in both groups. In the intervention group, a new gynaecological examination 6 months after the resection documents the presence of residual polyp or symptoms. The other group is examined again after 6 months of observation. Symptoms and findings with the second examination are compared with symptoms and findings at the first examination, any changes are documented and the final outcome in the to groups are compared.
Study Part 3: The occurrence and natural history of asymptomatic endometrial polyps in perimenopausal women. A prospective controlled study.
Registration of blood loss during menstruation is documented with the help of a standardized form (PBAC) and gynaecological examination including SIS of 1000 randomly selected women in the age group 45-50. Where endometrial polyps are identified, we document the size and number of polyps and an endometrial biopsy is taken. After including a woman with an endometrial polyp in the study, the next woman without endometrial polyp is recruited to the control group. After one year, blood loss during menstruation is registered again, and all women with endometrial polyps as well as the control group have a new examination including vaginal ultrasound, SIS and endometrial biopsy. Symptoms and findings are compared with symptoms and findings at the first examination and all changes are documented. If the woman has a persistent endometrial polyp when examined at 1 year, she is offered treatment with hysteroscopic polyp resection.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oslo, Norway, 0407
- Gynaecologial department, Ullevaal University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Study 1:
- Endometrial polyp (EP) group: Presence of endometrial polyp verified by vaginal ultrasound examination.
- Cancer group: Presence of endometrial cancer verified by histological examination.
Study 2:
- Pre- or perimenopausal women.
- Presence of endometrial polyp verified by vaginal ultrasound.
Study 3:
- EP group: Presence of endometrial polyp verified by vaginal ultrasound.
- Control group: Normal endometrium by vaginal ultrasound examination.
Exclusion Criteria:
- Study 1: Earlier severe allergic reactions.
Study 2:
- Postmenopausal patient.
- Pregnancy.
- Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.
Study 3:
- Previous hysterectomy.
- Pregnancy.
- Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer
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Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer
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Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group
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Study part 3. Change in PBAC score in women with endometrial polyps compared to control group
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Secondary Outcome Measures
Outcome Measure |
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Associated factors for the development of endometrial polyps
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Change in endometrial polyp size and symptoms after 6 and 12 months of observation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olav Istre, MD., PhD., Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PP I/II/III
- 22200205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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