NCT02412072

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 4, 2015

Last Update Submit

April 7, 2015

Conditions

Endometrial Hyperplasia

Keywords

Endometrial hyperplasiaProgesteroneLNG-IUSdilatation & curettageendometrial aspiration sampling

Outcome Measures

Primary Outcomes (1)

  • consistency of the endometrial aspiration biopsy and D&C after hormonal treatment of EH

    3months or 6 months

Secondary Outcomes (1)

  • response rate

    6 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with biopsy proven endometrial hyperplasia

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam CAH medical center

Seoul, Gangnamgu, South Korea

RECRUITING

Related Publications (1)

  • Kim MK, Seong SJ, Park DC, Hong JH, Roh JW, Kang SB. Comparison of diagnostic accuracy between endometrial curettage and aspiration biopsy in patients treated with progestin for endometrial hyperplasia: a Korean Gynecologic Oncology Group study. J Gynecol Oncol. 2020 Jul;31(4):e51. doi: 10.3802/jgo.2020.31.e51. Epub 2020 Feb 7.

    PMID: 32266800DERIVED

MeSH Terms

Conditions

Endometrial HyperplasiaDilatation, Pathologic

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Seok Ju Seong, Professor

CONTACT

: +82-2-3468-3672sjseongcheil@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2015

First Posted

April 8, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

KR(1)