Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-03-28 @ 1:05 PM
Study NCT ID:
NCT00979095
Status:
UNKNOWN
Last Update Posted:
2010-10-13
First Post:
2009-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Examination of Patients With Primary Multiple Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-12', 'studyFirstSubmitDate': '2009-09-15', 'studyFirstSubmitQcDate': '2009-09-16', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic expression of relevant genes between the groups', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': "Amount of serological biomarkers (MMP's) correlated to gene expression", 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple hernia'], 'conditions': ['Multiple Hernia']}, 'descriptionModule': {'briefSummary': "The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).\n\nThe hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.", 'detailedDescription': 'Other examinations performed on the patients enrolled in this study:\n\n* Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.\n* Beightons score to evaluate the degree of joint hypermobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Danish citizens. Data have been retracted from The Danish Hernia Database.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with minimum 3 primary hernias\n\nExclusion Criteria:\n\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT00979095', 'briefTitle': 'Genetic Examination of Patients With Primary Multiple Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Genetic Differences Between Patients With Multiple Hernia and a Healthy Control Group', 'orgStudyIdInfo': {'id': 'H-D-2008-126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple hernia', 'description': 'Patients with more than 3 primary hernias'}, {'label': 'Control group', 'description': 'Patients without hernias'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev Hospital', 'state': 'Herev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jakob Burcharth, MD', 'role': 'CONTACT', 'email': 'jakobburcharth@gmail.com', 'phone': '44884488', 'phoneExt': '89434'}, {'name': 'Jakob Burcharth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jacob Rosenberg'}], 'overallOfficials': [{'name': 'Jacob Rosenberg, Prof. MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Herlev Hospital'}, {'name': 'Jakob Burcharth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jakob Burcharth, MD.', 'oldOrganization': 'Herlev Hospital'}}}}