- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02412072
Comparison of Dilatation & Curettage and Endometrial Aspiration Biopsy Accuracy in Patients Treated With Progestin for Endometrial Hyperplasia: A Korean Gynecologic Oncology Group Study
Study Overview
Status
Conditions
Detailed Description
Endometrial hyperplasia (EH) is a premalignant lesion of endometrial cancer (EC), which is the most common gynecological malignancy in developed countries [1]. Therefore, accurate diagnostics and proper management of EH are clinically significant to prevent EC development.
The treatment modality of EH mostly depends on the histological diagnosis and the woman's desire to retain fertility. The risk of cancer progression is low for women with non-atypical EH (<5%) but increases up to 30% for women with atypical EH [2, 3]. In this respect, hysterectomy is recommended for the treatment of atypical EH. Meanwhile, for patients with non-atypical EH or for young patients with atypical EH who strongly desire to preserve their fertility, various conservative therapies using progestin have been used. Traditionally, orally administered progestins such as megestrol acetate (MA) and medroxyprogesterone acetate (MPA) are most commonly used method with various treatment regimens [4, 5]. More recently, the levonorgestrel-releasing intrauterine system (LNG-IUS), which achieves higher local concentrations of progestogens in the endometrium, with lower systemic side effects, also has been used successfully to treat EH [6-12].
However, there is no report about the accuracy of endometrial sampling during hormonal treatment for EH or the best technique for follow-up evaluation of EH. A recent study comparing the histological results of pipelle biopsy and D&C reported almost equal EH-diagnostic success rates [13]. Meanwhile, these results were obtained for cases where the LNG-IUS was not in the uterus and where there were no progestin effects on the endometrium.
Therefore, the investigators conducted a large multicenter prospective study to compare the diagnostic accuracy of endometrial aspiration biopsy with dilatation & curettage (D&C) in follow up evaluation of patients treated with progestin for EH.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Seok Ju Seong, Professor
- Phone Number: : +82-2-3468-3672
- Email: sjseongcheil@naver.com
Study Locations
-
-
Gangnamgu
-
Seoul, Gangnamgu, Korea, Republic of
- Recruiting
- Gangnam CAH medical center
-
Contact:
- Seok Ju Seong
- Email: sjseongcheil@yahoo.co.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who are histological confirmed as endometrial hyperplasia
- Patients who desire to preserve fertility potential.
- Patients signed the written informed consent voluntarily.
Exclusion Criteria:
- Pregnancy or suspected pregnancy.
- Patients who have severe underlying disease or complication.
- Treatment for metastatic cancer from other organs or cancer therapy within the preceding 5 years.
- Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity.
- Acute liver disease or kidney disease
- Thrombosis or phlebothrombosis requiring treatment.
- Genital (vaginal, uterine or ovarian) infection.
- Acute severe disease of the arteries, such as stroke or heart infarction, or a history of artery disease.
- Hypersensitivity to any component of this product.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
consistency of the endometrial aspiration biopsy and D&C after hormonal treatment of EH
Time Frame: 3months or 6 months
|
3months or 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- kgog2019
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