search
Back to results

Endometrial Polyps: Pathophysiology and Clinical Consequences

Primary Purpose

Endometrial Polyp, Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hysteroscopic resection of endometrial polyps. (TCRP)
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Polyp focused on measuring Endometrial polyps., Angiogenesis., Asymptomatic., Symptoms., Malignancy., Treatment efficiency., Vaginal bleeding.

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Gynaecologial department, Ullevaal University Hospital

Outcomes

Primary Outcome Measures

Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer
Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer
Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group
Study part 3. Change in PBAC score in women with endometrial polyps compared to control group

Secondary Outcome Measures

Associated factors for the development of endometrial polyps
Change in endometrial polyp size and symptoms after 6 and 12 months of observation

Full Information

First Posted
October 31, 2005
Last Updated
July 3, 2011
Sponsor
Ullevaal University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00247923
Brief Title
Endometrial Polyps: Pathophysiology and Clinical Consequences
Official Title
Endometrial Polyps. Pathophysiology and Clinical Consequences.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital

4. Oversight

5. Study Description

Brief Summary
The aim of these studies is to study the natural history, the symptoms of, as well as the effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study new diagnostic techniques to differentiate between malignant and benign endometrial polyps.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Polyp, Endometrial Cancer
Keywords
Endometrial polyps., Angiogenesis., Asymptomatic., Symptoms., Malignancy., Treatment efficiency., Vaginal bleeding.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1186 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic resection of endometrial polyps. (TCRP)
Primary Outcome Measure Information:
Title
Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer
Title
Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer
Title
Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group
Title
Study part 3. Change in PBAC score in women with endometrial polyps compared to control group
Secondary Outcome Measure Information:
Title
Associated factors for the development of endometrial polyps
Title
Change in endometrial polyp size and symptoms after 6 and 12 months of observation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Istre, MD., PhD.
Organizational Affiliation
Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynaecologial department, Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Endometrial Polyps: Pathophysiology and Clinical Consequences

We'll reach out to this number within 24 hrs