Determining Normal Range for Free Light Chains in Serum Among Twins

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04191057
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 76.6
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Device: Free light chains	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: The participant will not be given the results of the free light chain result
• Primary Purpose: Screening
• Official Title: Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins
• Actual Study Start Date: Aug 15, 2018
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy twin Free light chains of twins compared to non-twin siblings	Device: Free light chains; Blood samples will be collected and analyzed

Outcome Measures

Primary Outcome Measures

1. Free light chain reference range [One month after the completion of the enrollment]

   Determination of the normal range for free light chains

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94306

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Alan Wu, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04191057
• Other Study ID Numbers: 18-25508
• First Posted: Dec 9, 2019
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of California, San Francisco: free light chains; healthy twins
• Additional relevant MeSH terms: Multiple Myeloma

Study Results

No Results Posted as of Mar 25, 2022