CAN: Cooperative Adenomyosis Network
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Therapeutic effect and Diagnostics [2day]
Symptom Assessment
Secondary Outcome Measures
- Pathology [1day]
Diagnostic assessment
- selection of therapeutic scheme [1day]
pharmacotherapy or surgery
- vision algetic standard（VAS） [2day]
Semeiology and evaluative criteria
- B type ultrasound [1day]
Diagnostic assessment
- Magnetic Resonance Imaging [1day]
Diagnostic assessment
- pictorial blood loss assessment chart（PBAC） [2day]
Semeiology and evaluative criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
- Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.
Exclusion Criteria:
- Refusal to join the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lei Li | Beijing | China/Beiing | China | 100000 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Aijun AJ SUN, MD, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Study Documents (Full-Text)
More Information
Additional Information:
- Clinical Challenge
- Treatment Choices
- Fertility Outcome
- Medical Treatment
- ING-IUS
- Transvaginal Sonography
- MRI
Publications
- 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.
- 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.
- CAN201706