<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230994</url>
  </required_header>
  <id_info>
    <org_study_id>CAN201706</org_study_id>
    <nct_id>NCT03230994</nct_id>
  </id_info>
  <brief_title>Cooperative Adenomyosis Network</brief_title>
  <acronym>CAN</acronym>
  <official_title>A Study of Cooperative Network of Diagnosis and Treatment of Uterine Adenomyosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple&#xD;
      centers.Based on the Network platform and Database,the investigators try to explore the&#xD;
      diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In&#xD;
      addiction，the investigators expect to conduct research on the effect and the follow-up&#xD;
      fertility outcomes of different medical or surgical treatment, the etiology of AM and&#xD;
      endometriosis,the perspective investigation of the malignant transformation of AM ;the&#xD;
      high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical&#xD;
      Guidelines about AM which suitable to chinese conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      5000 women diagnosed of Adenomyosis(AM) with pathology, transvaginal ultrasonography or&#xD;
      magnetic resonance image（MRI）will be enrolled from nationwide multicenters. The investigators&#xD;
      would build up Network platform, and database with the registered data within 6 months.&#xD;
      30-month follow-up with an interval of at least once every 6 months will be done for every&#xD;
      patient ，and update the database timely.&#xD;
&#xD;
      Based on the Network platform and Database,we try to explore the diagnostic strategies for AM&#xD;
      and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators&#xD;
      expect to conduct research on the effect and the follow-up fertility outcomes of different&#xD;
      medical or surgical treatment,the etiology of AM and endometriosis,the perspective&#xD;
      investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally&#xD;
      propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to&#xD;
      chinese conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Months</target_duration>
  <primary_outcome>
    <measure>Therapeutic effect and Diagnostics</measure>
    <time_frame>2day</time_frame>
    <description>Symptom Assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathology</measure>
    <time_frame>1day</time_frame>
    <description>Diagnostic assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>selection of therapeutic scheme</measure>
    <time_frame>1day</time_frame>
    <description>pharmacotherapy or surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vision algetic standard（VAS）</measure>
    <time_frame>2day</time_frame>
    <description>Semeiology and evaluative criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B type ultrasound</measure>
    <time_frame>1day</time_frame>
    <description>Diagnostic assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic Resonance Imaging</measure>
    <time_frame>1day</time_frame>
    <description>Diagnostic assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pictorial blood loss assessment chart（PBAC）</measure>
    <time_frame>2day</time_frame>
    <description>Semeiology and evaluative criteria</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Dysmenorrhea</condition>
  <condition>Metrorrhagia</condition>
  <condition>Infertility, Female</condition>
  <condition>Pathology</condition>
  <condition>Ultrasonography</condition>
  <condition>Radiography</condition>
  <arm_group>
    <arm_group_label>Different Treatment Groups</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        5000 women diagnosed of adenomyosis by pathology or magnetic resonance image（MRI）by&#xD;
        experienced specialist physicians will be enrolled from nationwide multicenter.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to join the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Aijun AJ SUN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei L Li, MD</last_name>
    <phone>139-1198-8831</phone>
    <phone_ext>＋86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>China/Beiing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei L Li, MD</last_name>
      <phone>13911988831</phone>
      <phone_ext>+86</phone_ext>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis%3A+A+Clinical+Review+of+a+Challenging+Gynecologic+Condition.</url>
    <description>Clinical Challenge</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis%3A+What+the+Patient+Needs.+J+Minim+Invasive+Gynecol.</url>
    <description>Treatment Choices</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis+and+reproductive+performance+after+surgery+for+rectovaginal+and+colorectal+endometriosis%3A+a+systematic+review+and+meta-analysis.</url>
    <description>Fertility Outcome</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/27379972</url>
    <description>Medical Treatment</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/27356477</url>
    <description>ING-IUS</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Sonography+of+adenomyosis.+J+Ultrasound</url>
    <description>Transvaginal Sonography</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=An+update+on+adenomyosis.+Diagn+Interv+Imaging</url>
    <description>MRI</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>26427702</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26772777</PMID>
  </reference>
  <results_reference>
    <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):704-13. doi: 10.1016/j.rbmo.2014.02.006. Epub 2014 Mar 4.</citation>
    <PMID>24745831</PMID>
  </results_reference>
  <results_reference>
    <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. doi: 10.1080/09513590.2016.1197200. Epub 2016 Jul 5.</citation>
    <PMID>27379972</PMID>
  </results_reference>
  <results_reference>
    <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 Zhi. 2016 Jun 25;51(6):424-30. doi: 10.3760/cma.j.issn.0529-567X.2016.06.005. Chinese.</citation>
    <PMID>27356477</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>22535729</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>23246186</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>June 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Aijun Sun</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>adenomyosis</keyword>
  <keyword>diagnosis</keyword>
  <keyword>treatment</keyword>
  <keyword>epidemiology</keyword>
  <keyword>Complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
    <mesh_term>Metrorrhagia</mesh_term>
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Network platform, and the website will be attached later.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within twelve months after the trial complete</ipd_time_frame>
    <ipd_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_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03230994/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03230994/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230994
org study id: CAN201706
nct id: NCT03230994
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Therapeutic effect and Diagnostics
time frame: 2day
description: Symptom Assessment
measure: Pathology
time frame: 1day
description: Diagnostic assessment
measure: selection of therapeutic scheme
time frame: 1day
description: pharmacotherapy or surgery
measure: vision algetic standard（VAS）
time frame: 2day
description: Semeiology and evaluative criteria
measure: B type ultrasound
time frame: 1day
description: Diagnostic assessment
measure: Magnetic Resonance Imaging
time frame: 1day
description: Diagnostic assessment
measure: pictorial blood loss assessment chart（PBAC）
time frame: 2day
description: Semeiology and evaluative criteria
arm group label: Different Treatment Groups
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
last name: Aijun AJ SUN, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
last name: Lei L Li, MD
phone: 139-1198-8831
phone ext: ＋86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis%3A+A+Clinical+Review+of+a+Challenging+Gynecologic+Condition.
description: Clinical Challenge
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis%3A+What+the+Patient+Needs.+J+Minim+Invasive+Gynecol.
description: Treatment Choices
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis+and+reproductive+performance+after+surgery+for+rectovaginal+and+colorectal+endometriosis%3A+a+systematic+review+and+meta-analysis.
description: Fertility Outcome
url: https://www.ncbi.nlm.nih.gov/pubmed/27379972
description: Medical Treatment
url: https://www.ncbi.nlm.nih.gov/pubmed/27356477
description: ING-IUS
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Sonography+of+adenomyosis.+J+Ultrasound
description: Transvaginal Sonography
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=An+update+on+adenomyosis.+Diagn+Interv+Imaging
description: MRI
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.
PMID: 26427702
citation: 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.
PMID: 26772777
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):704-13. doi: 10.1016/j.rbmo.2014.02.006. Epub 2014 Mar 4.
PMID: 24745831
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. doi: 10.1080/09513590.2016.1197200. Epub 2016 Jul 5.
PMID: 27379972
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 Zhi. 2016 Jun 25;51(6):424-30. doi: 10.3760/cma.j.issn.0529-567X.2016.06.005. Chinese.
PMID: 27356477
citation: 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.
PMID: 22535729
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.
PMID: 23246186
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Aijun Sun
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Adenomyosis
mesh term: Metrorrhagia
mesh term: Dysmenorrhea
sharing ipd: Yes
ipd description: Network platform, and the website will be attached later.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within twelve months after the trial complete
ipd access criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
provided document: 
provided document: 