Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT01738932
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Polymorphisms of Mannan-binding Lectin (MBL)and Serum Levels of MBL in Patients With 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, EDTA blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of individuals with s-MBL < 100 ng/ml', 'timeFrame': 'baseline'}, {'measure': 'Frequency of individuals with MBL genotypes LXPA/O or O/O', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endometriosis', 'mannan-binding lectin', 'immunology'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '16600231', 'type': 'RESULT', 'citation': 'Kavoussi SK, Mueller MD, Lebovic DI. Expression of mannose-binding lectin in the peritoneal fluid of women with and without endometriosis. Fertil Steril. 2006 May;85(5):1526-8. doi: 10.1016/j.fertnstert.2005.10.032. Epub 2006 Apr 5.'}, {'pmid': '19917506', 'type': 'RESULT', 'citation': 'Ozerkan K, Oral B, Uncu G. Mannose-binding lectin levels in endometriosis. Fertil Steril. 2010 Jul;94(2):775-6. doi: 10.1016/j.fertnstert.2009.09.056. Epub 2009 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the possible association between low levels of MBL and the development of endometriosis', 'detailedDescription': 'Endometriosis is a chronic, inflammatory disease, affecting approximately 10% of the female population. The pathogenesis of endometriosis is still unclear, but several studies have indicated that the immune system is involved. It has been suggested that endometriosis should be considered an autoimmune disease, considering the findings of elevated levels of cytokines, decreased cell apoptosis, increased incidence of autoantibodies and a higher frequency of other autoimmune diseases in endometriosis patients. MBL participates in the innate immune defence by activating complement on the surfaces of microorganisms, but several studies have suggested that MBL is also involved in autoimmune diseases. The individual MBL level is highly variable due to a number of polymorphic sites in the structural gene and in the promoter region, and approximately 12 % of the normal population have very low serum MBL levels (\\<100 ng/ml).\n\nThe possible association between MBL and endometriosis has been investigated in two small studies, in which no association was found. The aim of the present study is to investigate the prevalence of individuals with low serum levels of MBL and with genotypes associated with low MBL production in a larger group of endometriosis patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Endometriosis patients referred to the endometriosis clinic at Aarhus University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically verified endometriosis\n* ASRM stage 2-4\n\nExclusion Criteria:\n\n* pregnancy\n* actual treatment with GnRh analog\n* autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT01738932', 'briefTitle': 'Genetic Polymorphisms of Mannan-binding Lectin (MBL)and Serum Levels of MBL in Patients With Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Genetic Polymorphisms of Mannan-binding Lectin (MBL) and Serum Levels of MBL in Patients With Endometriosis', 'orgStudyIdInfo': {'id': 'MBLendo06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'women with histologically verified endometriosis'}, {'label': 'Controls', 'description': 'Healthy Danish blood donors'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200 N', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Christina Kruse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}