Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 10:29 PM
Study NCT ID:
NCT03230994
Status:
UNKNOWN
Last Update Posted:
2018-11-13
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cooperative Adenomyosis Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-03', 'size': 96168, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-07-03T00:50', 'hasProtocol': False}, {'date': '2017-06-03', 'size': 2867705, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-07-03T01:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '30 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic effect and Diagnostics', 'timeFrame': '2day', 'description': 'Symptom Assessment'}], 'secondaryOutcomes': [{'measure': 'Pathology', 'timeFrame': '1day', 'description': 'Diagnostic assessment'}, {'measure': 'selection of therapeutic scheme', 'timeFrame': '1day', 'description': 'pharmacotherapy or surgery'}, {'measure': 'vision algetic standard（VAS）', 'timeFrame': '2day', 'description': 'Semeiology and evaluative criteria'}, {'measure': 'B type ultrasound', 'timeFrame': '1day', 'description': 'Diagnostic assessment'}, {'measure': 'Magnetic Resonance Imaging', 'timeFrame': '1day', 'description': 'Diagnostic assessment'}, {'measure': 'pictorial blood loss assessment chart（PBAC）', 'timeFrame': '2day', 'description': 'Semeiology and evaluative criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adenomyosis', 'diagnosis', 'treatment', 'epidemiology', 'Complications'], 'conditions': ['Dysmenorrhea', 'Metrorrhagia', 'Infertility, Female', 'Pathology', 'Ultrasonography', 'Radiography']}, 'referencesModule': {'references': [{'pmid': '26427702', 'type': 'BACKGROUND', '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': '26772777', 'type': 'BACKGROUND', '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': '24745831', 'type': 'RESULT', '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': '27379972', 'type': 'RESULT', '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': '27356477', 'type': 'RESULT', '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': '22535729', 'type': 'RESULT', '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': '23246186', 'type': 'RESULT', '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': '39805535', 'type': 'DERIVED', 'citation': 'Chen X, Lang J, Li L. Adenomyosis Patterns on Transvaginal Sonography Could Predict the Obstetrical Outcomes of Fertility-Sparing Surgeries: A Retrospective Cohort Study. J Minim Invasive Gynecol. 2025 Jun;32(6):540-549. doi: 10.1016/j.jmig.2025.01.003. Epub 2025 Jan 11.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis%3A+A+Clinical+Review+of+a+Challenging+Gynecologic+Condition.', 'label': 'Clinical Challenge'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Adenomyosis%3A+What+the+Patient+Needs.+J+Minim+Invasive+Gynecol.', 'label': '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.', 'label': 'Fertility Outcome'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27379972', 'label': 'Medical Treatment'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/27356477', 'label': 'ING-IUS'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Sonography+of+adenomyosis.+J+Ultrasound', 'label': 'Transvaginal Sonography'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=An+update+on+adenomyosis.+Diagn+Interv+Imaging', 'label': 'MRI'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBased 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '5000 women diagnosed of adenomyosis by pathology or magnetic resonance image（MRI）by experienced specialist physicians will be enrolled from nationwide multicenter.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.\n\nExclusion Criteria:\n\n* Refusal to join the study'}, 'identificationModule': {'nctId': 'NCT03230994', 'acronym': 'CAN', 'briefTitle': 'Cooperative Adenomyosis Network', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Study of Cooperative Network of Diagnosis and Treatment of Uterine Adenomyosis.', 'orgStudyIdInfo': {'id': 'CAN201706'}}, 'armsInterventionsModule': {'armGroups': [{'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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'China/Beiing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei L Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831', 'phoneExt': '+86'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei L Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '139-1198-8831', 'phoneExt': '＋86'}], 'overallOfficials': [{'name': 'Aijun AJ SUN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within twelve months after the trial complete', 'ipdSharing': 'YES', 'description': 'Network platform, and the website will be attached later.', 'accessCriteria': 'Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Aijun Sun', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}