Endometrial HyperplasiaNCT02412072
Comparison of Dilatation & Curettage and Endometrial Aspiration Biopsy Accuracy in Patients Treated With Progestin for Endometrial Hyperplasia: A Korean Gynecologic Oncology Group Study
An observational study of Endometrial Hyperplasia, run by Korean Gynecologic Oncology Group at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Hyperplasia
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with biopsy proven endometrial hyperplasia
Who may be able to join
- Patients who are histological confirmed as endometrial hyperplasia
- Patients who desire to preserve fertility potential.
- Patients signed the written informed consent voluntarily.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam CAH medical center
Seoul, Gangnamgu
Seok Ju Seong, sjseongcheil@yahoo.co.kr
About this study
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.
Read the 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.
- Conditions
- Endometrial Hyperplasia
- Keywords
- Endometrial hyperplasia, Progesterone, LNG-IUS, dilatation & curettage, endometrial aspiration sampling
- Medical subject headings
- Endometrial Hyperplasia, Dilatation, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
consistency of the endometrial aspiration biopsy and D&C after hormonal treatment of EH
Measured: 3months or 6 months
Secondary outcomes (1)
response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Gynecologic Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412072
- Sponsor's protocol ID
- kgog2019
- Status last verified
- Apr 2015
- First submitted
- 4 Apr 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32266800
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dilatation & Curettage and Endometrial Aspiration Biopsy Accuracy in Patients Treated With Progestin for Endometrial Hyperplasia: A Korean Gynecologic Oncology Group Study
- ClinicalTrials.gov ID
- NCT02412072
- Acronym / sponsor ID
- kgog2019
- Conditions
- Endometrial Hyperplasia
- Keywords
- Endometrial hyperplasia, Progesterone, LNG-IUS, dilatation & curettage, endometrial aspiration sampling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Korean Gynecologic Oncology GroupUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with biopsy proven endometrial hyperplasia
Key inclusion criteria (3 listed)
- Patients who are histological confirmed as endometrial hyperplasia
- Patients who desire to preserve fertility potential.
- Patients signed the written informed consent voluntarily.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
consistency of the endometrial aspiration biopsy and D&C after hormonal treatment of EH
Time frame: 3months or 6 months
1 secondary outcome
response rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Derived from this study: PubMed 32266800Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Hyperplasia, run by Korean Gynecologic Oncology Group at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seok Ju Seong, Professor (: +82-2-3468-3672, sjseongcheil@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consistency of the endometrial aspiration biopsy and D&C after hormonal treatment of EH (time frame: 3months or 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.