Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT04191057
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Normal Range for Free Light Chains in Serum Among Twins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The participant will not be given the results of the free light chain result'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free light chain reference range', 'timeFrame': 'One month after the completion of the enrollment', 'description': 'Determination of the normal range for free light chains'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['free light chains', 'healthy twins'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '22981867', 'type': 'BACKGROUND', 'citation': 'Braga F, Infusino I, Dolci A, Panteghini M. Biological variation of free light chains in serum. Clin Chim Acta. 2013 Jan 16;415:10-1. doi: 10.1016/j.cca.2012.09.008. Epub 2012 Sep 11. No abstract available.'}, {'pmid': '12194920', 'type': 'BACKGROUND', 'citation': 'Katzmann JA, Clark RJ, Abraham RS, Bryant S, Lymp JF, Bradwell AR, Kyle RA. Serum reference intervals and diagnostic ranges for free kappa and free lambda immunoglobulin light chains: relative sensitivity for detection of monoclonal light chains. Clin Chem. 2002 Sep;48(9):1437-44.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to recruit healthy adult identical and fraternal twins for the collection of one teaspoon of blood to be sent to the Clinical Lab at San Francisco General Hospital. The serum will be tested to determine the reference range for free light chains.', 'detailedDescription': 'Serum free light chains are used to assist in the diagnosis of multiple myeloma. The test measures kappa (K) and lambda (L) chains, and the calculation of the ratio of kappa to lambda (K/L). Previous studies have shown that the K/L ratio does not change over time (1 year). The hypothesis of this study is that healthy twins will have a K/L ratio that are close to each other in value, suggesting that this ratio is genetically linked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects 18-80 years.\n* Must be an identical or fraternal twin (both must be recruited)\n\nExclusion Criteria:\n\n* Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -'}, 'identificationModule': {'nctId': 'NCT04191057', 'briefTitle': 'Determining Normal Range for Free Light Chains in Serum Among Twins', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins', 'orgStudyIdInfo': {'id': '18-25508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy twin', 'description': 'Free light chains of twins compared to non-twin siblings', 'interventionNames': ['Other: Free light chains']}], 'interventions': [{'name': 'Free light chains', 'type': 'OTHER', 'description': 'Blood samples will be collected and analyzed', 'armGroupLabels': ['Healthy twin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94306', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Alan Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participants and other researchers will not have access to data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}