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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03230994
Other study ID # CAN201706
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2017
Est. completion date December 30, 2020

Study information

Verified date November 2018
Source Peking Union Medical College Hospital
Contact Lei L Li, MD
Phone 139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple centers.Based on the Network platform and Database,the investigators try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction,the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment, the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.


Description:

5000 women diagnosed of Adenomyosis(AM) with pathology, transvaginal ultrasonography or magnetic resonance image(MRI)will be enrolled from nationwide multicenters. The investigators would build up Network platform, and database with the registered data within 6 months. 30-month follow-up with an interval of at least once every 6 months will be done for every patient ,and update the database timely.

Based on the Network platform and Database,we try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction,the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment,the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.

Exclusion Criteria:

- Refusal to join the study

Study Design


Locations

Country Name City State
China Lei Li Beijing China/Beiing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Alabiso G, Alio L, Arena S, Barbasetti di Prun A, Bergamini V, Berlanda N, Busacca M, Candiani M, Centini G, Di Cello A, Exacoustos C, Fedele L, Fuggetta E, Gabbi L, Geraci E, Imperiale L, Lavarini E, Incandela D, Lazzeri L, Luisi S, Maiorana A, Maneschi F, Mannini L, Mattei A, Muzii L, Pagliardini L, Perandini A, Perelli F, Pinzauti S, Porpora MG, Remorgida V, Leone Roberti Maggiore U, Seracchioli R, Solima E, Somigliana E, Tosti C, Venturella R, Vercellini P, Viganò P, Vignali M, Zannoni L, Zullo F, Zupi E; Endometriosis Treatment Italian Club. Adenomyosis: What the Patient Needs. J Minim Invasive Gynecol. 2016 May-Jun;23(4):476-88. doi: 10.1016/j.jmig.2015.12.017. Epub 2016 Jan 6. Review. — View Citation

Levy G, Dehaene A, Laurent N, Lernout M, Collinet P, Lucot JP, Lions C, Poncelet E. An update on adenomyosis. Diagn Interv Imaging. 2013 Jan;94(1):3-25. doi: 10.1016/j.diii.2012.10.012. Epub 2012 Dec 12. Review. — View Citation

Li L, Leng JH, Shi JH, Zhang JJ, Jia SZ, Li XY, Dai Y, Zhang JR, Li T, Xu XX, Liu ZZ, You SS, Chang XY, Lang JH. [A prospective study on the effects of levonorgestrel-releasing intrauterine system for adenomyosis with menorrhagia]. Zhonghua Fu Chan Ke Za — View Citation

Pontis A, D'Alterio MN, Pirarba S, de Angelis C, Tinelli R, Angioni S. Adenomyosis: a systematic review of medical treatment. Gynecol Endocrinol. 2016 Sep;32(9):696-700. Epub 2016 Jul 5. Review. — View Citation

Sakhel K, Abuhamad A. Sonography of adenomyosis. J Ultrasound Med. 2012 May;31(5):805-8. Review. — View Citation

Struble J, Reid S, Bedaiwy MA. Adenomyosis: A Clinical Review of a Challenging Gynecologic Condition. J Minim Invasive Gynecol. 2016 Feb 1;23(2):164-85. doi: 10.1016/j.jmig.2015.09.018. Epub 2015 Sep 30. Review. — View Citation

Vercellini P, Consonni D, Barbara G, Buggio L, Frattaruolo MP, Somigliana E. Adenomyosis and reproductive performance after surgery for rectovaginal and colorectal endometriosis: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Jun;28(6): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic effect and Diagnostics Symptom Assessment 2day
Secondary Pathology Diagnostic assessment 1day
Secondary selection of therapeutic scheme pharmacotherapy or surgery 1day
Secondary vision algetic standard(VAS) Semeiology and evaluative criteria 2day
Secondary B type ultrasound Diagnostic assessment 1day
Secondary Magnetic Resonance Imaging Diagnostic assessment 1day
Secondary pictorial blood loss assessment chart(PBAC) Semeiology and evaluative criteria 2day
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