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NCT04191057 Clinical Trial

Determining Normal Range for Free Light Chains in Serum Among Twins

Multiple Myeloma Clinical Trial

Official title:
Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04191057
Other study ID # 18-25508
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2018
Est. completion date January 1, 2024

Study information
Verified date June 2024
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Healthy subjects 18-80 years. - Must be an identical or fraternal twin (both must be recruited) Exclusion Criteria: - Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Free light chains
Blood samples will be collected and analyzed

Locations
Country Name City State
United States San Francisco General Hospital San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — View 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 Che — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Free light chain reference range Determination of the normal range for free light chains One month after the completion of the enrollment
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