Ultrasound and Endometrial Hyperplasia
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Вход / Регистрация
Линкът е запазен в клипборда
СъстояниеПрекратено
Спонсори
Milton S. Hershey Medical Center
Сътрудници
Center for Research on Women and Health
КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT00123188
BioSeek: nct00123188
Ключови думи
Резюме
The investigators hypothesize that endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.
Описание
The objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an "at risk" cohort. Endometrial carcinoma is an understudied cancer. This study will provide benefit regardless of its outcome, because it will be the first prospectively designed screening trial in an asymptomatic population.
Дати
| Последна проверка: | 12/31/2014 |
| Първо изпратено: | 07/19/2005 |
| Очаквано записване подадено: | 07/20/2005 |
| Първо публикувано: | 07/21/2005 |
| Изпратена последна актуализация: | 01/15/2015 |
| Последна актуализация публикувана: | 01/18/2015 |
| Действителна начална дата на проучването: | 03/31/2005 |
| Приблизителна дата на първично завършване: | 08/31/2009 |
| Очаквана дата на завършване на проучването: | 08/31/2009 |
Състояние или заболяване
Endometrial Hyperplasia
Интервенция / лечение
Procedure: Ultrasound and Biopsy
Фаза
-
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Ultrasound and Biopsy Transvaginal Ultrasound and Endometrial Biopsy | Procedure: Ultrasound and Biopsy Transvaginal ultrasound and Endometrial Biopsy |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 45 Years Да се 45 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension Exclusion Criteria: - Women who have had a hysterectomy |
Резултат
Първични изходни мерки
1. Endometrial Hyperplasia [End of study]
A transvaginal ultrasound of the endometrium will be performed to obtain measures of the anteroposterior endometrial thickness (in the sagittal plane), the dimensions of the endometrial cavity (thickness, length and width), and the appearance of the endometrium in addition to uterine and ovarian measures. Endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with the metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.
Вторични изходни мерки
1. Endometrial Cancer [End of study]
All women will then undergo an endometrial biopsy. The pipelle has been shown to be an accurate method of diagnosing endometrial cancer comparable to a full dilatation and curettage of the uterus. We believe it is important to perform a biopsy even in women with a thin endometrial stripe (<5mm), as it will be important for determining the specificity and negative predictive value of both ultrasound and any serum screening strategy we devise.
