Endometrial Polyps: Pathophysiology and Clinical Consequences

July 3, 2011 updated by: Ullevaal University Hospital

Endometrial Polyps. Pathophysiology and Clinical Consequences.

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

1186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0407
        • Gynaecologial department, Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 88 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olav Istre, MD., PhD., Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

February 1, 2009

More Information

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.

Clinical Trials on Endometrial Cancer

Clinical Trials on Hysteroscopic resection of endometrial polyps. (TCRP)

3
Subscribe