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Determining Normal Range for Free Light Chains in Serum Among Twins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191057
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 Not Applicable

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 geneticallyl linked.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : August 15, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Free light chain reference range [ Time Frame: One month after the completion of the enrollment ]
    Determination of the normal range for free light chains



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191057


Contacts
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Contact: Alan Wu, PhD 628-206-3540 alan.wu@ucsf.edu
Contact: Bee Ong 628-206-4239 chuimei.ong@ucsf.edu

Locations
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United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94306
Contact: Alan Wu, Ph.D.    628-206-3540    alan.wu@ucsf.edu   
Contact: Bee Ong    628-206-4239    chuimei.ong@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Alan Wu, PhD University of California, San Francisco

Publications of Results:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04191057    
Other Study ID Numbers: 18-25508
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants and other researchers will not have access to data.

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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:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases