Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01351051
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2011-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1008}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2011-04-08', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.', 'timeFrame': 'Enrolment visit'}], 'secondaryOutcomes': [{'measure': 'Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.', 'timeFrame': 'Enrolment visit'}, {'measure': 'Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.', 'timeFrame': 'Enrolment visit'}, {'measure': "Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.", 'timeFrame': 'Enrolment visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '30577792', 'type': 'DERIVED', 'citation': 'Dai Y, Zhou Y, Zhang X, Xue M, Sun P, Leng J, Chapron C. Factors associated with deep infiltrating endometriosis versus ovarian endometrioma in China: a subgroup analysis from the FEELING study. BMC Womens Health. 2018 Dec 22;18(1):205. doi: 10.1186/s12905-018-0697-7.'}, {'pmid': '27342743', 'type': 'DERIVED', 'citation': 'Chapron C, Lang JH, Leng JH, Zhou Y, Zhang X, Xue M, Popov A, Romanov V, Maisonobe P, Cabri P. Factors and Regional Differences Associated with Endometriosis: A Multi-Country, Case-Control Study. Adv Ther. 2016 Aug;33(8):1385-407. doi: 10.1007/s12325-016-0366-x. Epub 2016 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication excluding pregnancy in the last 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is a female aged between 18 and 41 years\n* The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months\n* The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis\n* The subject has given a written informed consent prior to any study-related procedures\n\nExclusion Criteria:\n\n* The subject is pregnant\n* The subject's surgery results showed evidence of malignancy\n* The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude"}, 'identificationModule': {'nctId': 'NCT01351051', 'acronym': 'FEELING', 'briefTitle': 'A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis', 'orgStudyIdInfo': {'id': 'A-38-52014-185'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No endometriosis'}, {'label': 'Superficial endometriosis'}, {'label': 'Endometrioma'}, {'label': 'Deep infiltrating endometriosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Zhejiang', 'country': 'China', 'facility': "Women's Hospital School of Medicine, Zhejiang University", 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital St Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Ivanovo', 'country': 'Russia', 'facility': 'Research Institute of Maternity and Childhood named after V.N. Gorodkov', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}