Endometrial Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 1186 |
Est. completion date | February 2009 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Gynaecologial department, Ullevaal University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Ullevaal University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer | |||
Primary | Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer | |||
Primary | Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group | |||
Primary | Study part 3. Change in PBAC score in women with endometrial polyps compared to control group | |||
Secondary | Associated factors for the development of endometrial polyps | |||
Secondary | Change in endometrial polyp size and symptoms after 6 and 12 months of observation |
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