Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT00326534
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2006-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rickettsial Genesis to Sarcoidosis in Denmark
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D012282', 'term': 'Rickettsia Infections'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012288', 'term': 'Rickettsiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-06', 'studyFirstSubmitDate': '2006-05-15', 'studyFirstSubmitQcDate': '2006-05-15', 'lastUpdatePostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcoidosis', 'Rickettsia', 'Serological reactions', 'Polymerase chain reaction'], 'conditions': ['Sarcoidosis', 'Rickettsia Infections']}, 'referencesModule': {'references': [{'pmid': '15516677', 'type': 'BACKGROUND', 'citation': 'Planck A, Eklund A, Grunewald J, Vene S. No serological evidence of Rickettsia helvetica infection in Scandinavian sarcoidosis patients. Eur Respir J. 2004 Nov;24(5):811-3. doi: 10.1183/09031936.04.00014604.'}, {'pmid': '11930323', 'type': 'BACKGROUND', 'citation': 'Nilsson K, Pahlson C, Lukinius A, Eriksson L, Nilsson L, Lindquist O. Presence of Rickettsia helvetica in granulomatous tissue from patients with sarcoidosis. J Infect Dis. 2002 Apr 15;185(8):1128-38. doi: 10.1086/339962. Epub 2002 Mar 21.'}, {'pmid': '20298335', 'type': 'RESULT', 'citation': 'Svendsen CB, Milman N, Hoier-Madsen M, Dziegiel MH, Krogfelt KA. Determination of rickettsial and antinuclear antibodies in Danish patients with sarcoidosis. Clin Respir J. 2008 Oct;2(4):202-7. doi: 10.1111/j.1752-699X.2008.00051.x.'}]}, 'descriptionModule': {'briefSummary': 'One study has suggested a connection between an infection with Rickettsia species and sarcoidosis finding molecular evidence of rickettsial deoxyribonucleic acid (DNA) in two patients. Another study found no antibodies in twenty Swedish patients with sarcoidosis.\n\nThis study will further enhance the subject by three different approaches in Danish patients.\n\nThe purpose of this study is to find serological and molecular evidence of an infection with Rickettsia species in Danish patients with sarcoidosis.', 'detailedDescription': 'The study has three approaches to the subject:\n\n1. A serological survey of rickettsial immunoglobin G (IgG)-antibodies in 50 patients with sarcoidosis compared to 50 blood donors without sarcoidosis.\n2. An archival study using pre-existing lymph node biopsies, where immunohistochemical analysis, fluorescent in situ hybridization, and polymerase chain reaction will be applied to samples from 50 patients with sarcoidosis and compared to 50 patients without sarcoidosis and 10 patients with tuberculosis.\n3. A prospective study using bronchoscopically obtained samples from 20 patients with sarcoidosis, compared to 20 patients without sarcoidosis. The study applies the same techniques as the second study, but enhancing the information from the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion\n\nExclusion Criteria:\n\n* Pregnant patients\n* Patients under the age of 18\n* Patients without consent\n* Patients with a registered wish of not having their samples used for research'}, 'identificationModule': {'nctId': 'NCT00326534', 'briefTitle': 'Rickettsial Genesis to Sarcoidosis in Denmark', 'organization': {'class': 'OTHER', 'fullName': 'Statens Serum Institut'}, 'officialTitle': 'Rickettsial Genesis to Sarcoidosis in Denmark', 'orgStudyIdInfo': {'id': 'KF 01 303797'}, 'secondaryIdInfos': [{'id': '2006-41-6575'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy'}, {'label': 'Sarcoidosis patients', 'description': 'Patients with newly diagnosed sarcoidosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300', 'city': 'Copenhagen S', 'country': 'Denmark', 'facility': 'Denmark'}], 'overallOfficials': [{'name': 'Claus B Svendsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Nils Milman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Karen A Krogfelt, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Statens Serum Institut'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Statens Serum Institut', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, {'name': 'Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Claus Bo Svendsen, MD', 'oldOrganization': 'Statens Serum Institut'}}}}