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Heavy Light Chain in Chronic Lymphocytic Leukemia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377869
Recruitment Status : Unknown
Verified February 2015 by tamar.tadmor, Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Collaborators:
Rambam Health Care Campus
Laniado Hospital
Meir Medical Center
Rabin Medical Center
Kaplan Medical Center
Shaare Zedek Medical Center
Hadassah Medical Organization
HaEmek Medical Center, Israel
Western Galilee Hospital-Nahariya
Tel-Aviv Sourasky Medical Center
Assaf-Harofeh Medical Center
Information provided by (Responsible Party):
tamar.tadmor, Bnai Zion Medical Center

Brief Summary:

Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which enables improvement in paraprotein detection and monitoring in multiple myeloma and other plasma-cell dyscrasias.

The prognostic and biological role of the HLC assay has as yet not been studied in CLL.

Aims of the proposed study:

  1. To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL patients. (In addition to FLC)
  2. To study the different patterns of Immunoglobulin's subclass antibodies in the serum of patients with CLL and compare them to those of to healthy volunteers.
  3. To perform a sub-analysis in patients with CLL who have autoimmune phenomenon (AIHA and ITP)

Condition or disease Intervention/treatment
CLL Other: No intervantion

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heavy Light Chain in Chronic Lymphocytic Leukemia
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 1) To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL patients. (In addition to FLC) [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age>18 years Patients diagnosed with CLL
Criteria

Inclusion Criteria:

New diagnosed patients with CLL (untreated)

Exclusion Criteria:

Not treated with immunoglobulin Not treated with steroids


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): NCT02377869


Locations
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Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Tamar Tadmor, MD    +97248359 ext 407    tamar.tadmor@b-zion.org.il   
Sponsors and Collaborators
Bnai Zion Medical Center
Rambam Health Care Campus
Laniado Hospital
Meir Medical Center
Rabin Medical Center
Kaplan Medical Center
Shaare Zedek Medical Center
Hadassah Medical Organization
HaEmek Medical Center, Israel
Western Galilee Hospital-Nahariya
Tel-Aviv Sourasky Medical Center
Assaf-Harofeh Medical Center
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Responsible Party: tamar.tadmor, MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02377869    
Other Study ID Numbers: 0018-14-BNZ
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell