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Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease (B-RAF V600E)

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. Identifier: NCT01720758
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:
The presence of a specific mutation in the gene known as B-RAF has been found in patients who have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be ascertained in peripheral blood samples of patients who have this disease and in a group of patients who have a similar chronic lymphoproliferative conditions such as splenic marginal lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis of Hairy Cell Leukemia and determine whether patients are in remission.

Condition or disease
Hairy Cell Leukemia Splenic Marginal Zone Lymphoma

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease.
Actual Study Start Date : November 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Primary Outcome Measures :
  1. detection of the B-RAF V600E mutation [ Time Frame: 2 weeks ]

Biospecimen Retention:   Samples With DNA
perpheral blood

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:   No
Sampling Method:   Probability Sample
Study Population
Patients who are followed up in the Haematology Department in the Emek Medical Center for Hairy Cell Leukemia or chronic lymphoproliferative disease such as Splenic Marginal Zone Lymphoma. Patients who are examined and suspected to have Hairy Cell Leukemia.

Inclusion Criteria:

Patients over the age of 18 years -

Exclusion Criteria:

Patients less than 18 years in age or mentally defectives.


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Responsible Party: HaEmek Medical Center, Israel Identifier: NCT01720758    
Other Study ID Numbers: EMC-0124-11-CTIL
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Lymphoma, B-Cell, Marginal Zone
Leukemia, Hairy Cell
Lymphoproliferative Disorders
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases