Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT02258035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2014-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum will be derived from 100-150 ml of blood and used for protein purification'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D binding protein binding characteristics (affinity constant)', 'timeFrame': 'single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer', 'description': 'In vitro characterization'}], 'secondaryOutcomes': [{'measure': 'Correlation coefficient (r) of different DBP assays', 'timeFrame': 'single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer', 'description': 'In vitro characterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D binding protein (DBP)'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '22623648', 'type': 'BACKGROUND', 'citation': 'Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonne AS, Paridaens R, Neven P, Christiaens MR, Bouillon R, Wildiers H. Vitamin D status at breast cancer diagnosis: correlation with tumor characteristics, disease outcome, and genetic determinants of vitamin D insufficiency. Carcinogenesis. 2012 Jul;33(7):1319-26. doi: 10.1093/carcin/bgs187. Epub 2012 May 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with known genotype of DBP/Gc, as identified in the clinical database of the Multidisciplinary Breast Centre, University Hospitals Leuven, and free of breast cancer recurrence at the time of blood sampling.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype\n\nExclusion Criteria:\n\n* Inability to provide written informed consent\n* No children or pregnant women\n* Persons with known abnormal serum proteins'}, 'identificationModule': {'nctId': 'NCT02258035', 'briefTitle': 'Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Isolation of Genotype-specific Isoforms of Human Vitamin D-binding Protein (DBP/Gc)', 'orgStudyIdInfo': {'id': 's57027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DBP/Gc1f-1f genotype', 'description': 'Human volunteers homozygous for the 1f-1f (fast) genotype of DBP.', 'interventionNames': ['Other: Blood draw']}, {'label': 'DBP/Gc1s-1s genotype', 'description': 'Human volunteers homozygous for the 1s-1s (slow) genotype of DBP.', 'interventionNames': ['Other: Blood draw']}, {'label': 'DBP/Gc 2-2 genotype', 'description': 'Human volunteers homozygous for the 2-2 genotype of DBP.', 'interventionNames': ['Other: Blood draw']}], 'interventions': [{'name': 'Blood draw', 'type': 'OTHER', 'description': 'Sampling of 100-150 ml of blood', 'armGroupLabels': ['DBP/Gc 2-2 genotype', 'DBP/Gc1f-1f genotype', 'DBP/Gc1s-1s genotype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Dirk Vanderschueren, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}, {'name': 'Roger Bouillon, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UZ Leuven'}, {'name': 'Hans Wildiers, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}