Comparison of Dilatation & Curettage and Endometrial Aspiration Biopsy Accuracy in Patients Treated With Progestin for Endometrial Hyperplasia: A Korean Gynecologic Oncology Group Study

April 7, 2015 updated by: Korean Gynecologic Oncology Group
A prospective multicenter trial has been started in Korea to evaluate the diagnostic accuracy of endometrial aspiration biopsy compared with D&C in patients treated with progestin for endometrial hyperplasia (EH). For conservative treatment of EH, oral progestins are most commonly used method with various treatment regimens and more recently, the levonorgestrel-releasing intrauterine system (LNG-IUS) also has been used successfully to treat EH. However, there is no report about the accuracy of endometrial sampling during hormonal treatment for follow-up evaluation of EH. Patients with histologically confirmed EH are offered hormonal treatment, one of the following 3 options: oral medroxyprogesterone acetate(MPA) 10mg/day for 14days per cycle, continuous oral MPA 10mg/day, or insertion of LNG-IUS. Histological surveillance is performed at 3-months or 6-months following initial treatment. Endometrial tissues are obtained via endometrial aspiration biopsy using a pipelle and D&C. In case of using LNG-IUS, endometrial aspiration biopsy will be done with LNG-IUS in uterus and then, after removal of LNG-IUS, D&C will be done. The biopsy findings will be compared. The primary endpoint is the consistency of the results of the endometrial aspiration biopsy and D&C. The secondary endpoint is the response rate with 3 types of progestin treatment at 6 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients with biopsy proven endometrial hyperplasia

Description

Inclusion Criteria:

  1. Patients who are histological confirmed as endometrial hyperplasia
  2. Patients who desire to preserve fertility potential.
  3. Patients signed the written informed consent voluntarily.

Exclusion Criteria:

  1. Pregnancy or suspected pregnancy.
  2. Patients who have severe underlying disease or complication.
  3. Treatment for metastatic cancer from other organs or cancer therapy within the preceding 5 years.
  4. Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity.
  5. Acute liver disease or kidney disease
  6. Thrombosis or phlebothrombosis requiring treatment.
  7. Genital (vaginal, uterine or ovarian) infection.
  8. Acute severe disease of the arteries, such as stroke or heart infarction, or a history of artery disease.
  9. Hypersensitivity to any component of this product.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
response rate
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korean Gynecologic Oncology Group

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • kgog2019

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