CAN: Cooperative Adenomyosis Network

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03230994
Collaborator
(none)
5,000
1
42
119

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

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Study of Cooperative Network of Diagnosis and Treatment of Uterine Adenomyosis.
    Actual Study Start Date :
    Jun 30, 2017
    Anticipated Primary Completion Date :
    Jun 30, 2020
    Anticipated Study Completion Date :
    Dec 30, 2020

    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

    1. Therapeutic effect and Diagnostics [2day]

      Symptom Assessment

    Secondary Outcome Measures

    1. Pathology [1day]

      Diagnostic assessment

    2. selection of therapeutic scheme [1day]

      pharmacotherapy or surgery

    3. vision algetic standard(VAS) [2day]

      Semeiology and evaluative criteria

    4. B type ultrasound [1day]

      Diagnostic assessment

    5. Magnetic Resonance Imaging [1day]

      Diagnostic assessment

    6. pictorial blood loss assessment chart(PBAC) [2day]

      Semeiology and evaluative criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    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:

    Publications

    Responsible Party:
    Aijun Sun, Professor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03230994
    Other Study ID Numbers:
    • CAN201706
    First Posted:
    Jul 27, 2017
    Last Update Posted:
    Nov 13, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aijun Sun, Professor, Peking Union Medical College Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 13, 2018