Determining Normal Range for Free Light Chains in Serum Among Twins
Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-myeloma
Started Aug 2018
Longer than P75 for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2018
CompletedFirst Submitted
Initial submission to the registry
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJanuary 14, 2025
January 1, 2025
5.4 years
December 5, 2019
January 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Free light chain reference range
Determination of the normal range for free light chains
One month after the completion of the enrollment
Study Arms (1)
Healthy twin
EXPERIMENTALFree light chains of twins compared to non-twin siblings
Interventions
Eligibility Criteria
You may qualify if:
- Healthy subjects 18-80 years.
- Must be an identical or fraternal twin (both must be recruited)
You may not qualify if:
- Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco General Hospital
San Francisco, California, 94306, United States
Related Publications (2)
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: 22981867BACKGROUNDKatzmann 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.
PMID: 12194920BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Wu, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The participant will not be given the results of the free light chain result
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 9, 2019
Study Start
August 15, 2018
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
January 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Participants and other researchers will not have access to data.