Cooperative Adenomyosis Network (CAN)

A Study of Cooperative Network of Diagnosis and Treatment of Uterine Adenomyosis.

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.

Study Overview

• Status: Unknown
• Conditions: Ultrasonography; Dysmenorrhea; Metrorrhagia; Infertility, Female; Radiography; Pathology

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• China
  • China/Beiing
    • Beijing, China/Beiing, China, 100000
      • Recruiting
      • Lei Li
      • Contact: Lei L Li, MD; Phone Number: +86 13911988831; Email: lileigh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

5000 women diagnosed of adenomyosis by pathology or magnetic resonance image（MRI）by experienced specialist physicians will be enrolled from nationwide multicenter.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to join the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Different Treatment Groups; Women would receive different pharmacotherapy from the standard approach，such as levonorgestrel-releasing intrauterine system(LNG-IUS)，Gonadotrophin releasing hormone agonist(GnRH-a),surgery,etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic effect and Diagnostics	Symptom Assessment	2day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathology	Diagnostic assessment	1day
selection of therapeutic scheme	pharmacotherapy or surgery	1day
vision algetic standard（VAS）	Semeiology and evaluative criteria	2day
B type ultrasound	Diagnostic assessment	1day
Magnetic Resonance Imaging	Diagnostic assessment	1day
pictorial blood loss assessment chart（PBAC）	Semeiology and evaluative criteria	2day

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Aijun AJ SUN, MD, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Publications and helpful links

General Publications

• 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.
• 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, Vigano 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.
• 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):704-13. doi: 10.1016/j.rbmo.2014.02.006. Epub 2014 Mar 4.
• 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. doi: 10.1080/09513590.2016.1197200. Epub 2016 Jul 5.
• 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 Zhi. 2016 Jun 25;51(6):424-30. doi: 10.3760/cma.j.issn.0529-567X.2016.06.005. Chinese.
• Sakhel K, Abuhamad A. Sonography of adenomyosis. J Ultrasound Med. 2012 May;31(5):805-8. doi: 10.7863/jum.2012.31.5.805. No abstract available.
• 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.

Helpful Links

• Clinical Challenge
• Treatment Choices
• Fertility Outcome
• Medical Treatment
• ING-IUS
• Transvaginal Sonography
• MRI

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: treatment; epidemiology; Complications; diagnosis; adenomyosis
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Pelvic Pain; Uterine Hemorrhage; Infertility; Dysmenorrhea; Adenomyosis; Metrorrhagia; Infertility, Female
• Other Study ID Numbers: CAN201706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Network platform, and the website will be attached later.
• IPD Sharing Time Frame: Within twelve months after the trial complete
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No