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Determining Normal Range for Free Light Chains in Serum Among Twins

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Free light chains
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Multiple Myeloma focused on measuring free light chains, healthy twins

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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) -

Sites / Locations

  • San Francisco General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy twin

Arm Description

Free light chains of twins compared to non-twin siblings

Outcomes

Primary Outcome Measures

Free light chain reference range
Determination of the normal range for free light chains

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
August 10, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04191057
Brief Title
Determining Normal Range for Free Light Chains in Serum Among Twins
Official Title
Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
free light chains, healthy twins

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The participant will not be given the results of the free light chain result
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy twin
Arm Type
Experimental
Arm Description
Free light chains of twins compared to non-twin siblings
Intervention Type
Device
Intervention Name(s)
Free light chains
Intervention Description
Blood samples will be collected and analyzed
Primary Outcome Measure Information:
Title
Free light chain reference range
Description
Determination of the normal range for free light chains
Time Frame
One month after the completion of the enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Wu, PhD
Phone
628-206-3540
Email
alan.wu@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bee Ong
Phone
628-206-4239
Email
chuimei.ong@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Wu, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Wu, Ph.D.
Phone
628-206-3540
Email
alan.wu@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Bee Ong
Phone
628-206-4239
Email
chuimei.ong@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants and other researchers will not have access to data.
Citations:
PubMed Identifier
22981867
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.
Results Reference
result
PubMed Identifier
12194920
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.
Results Reference
result

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Determining Normal Range for Free Light Chains in Serum Among Twins

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