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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720758
First Posted: November 2, 2012
Last Update Posted: August 11, 2017
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.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  Purpose
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
Hairy Cell Leukemia Splenic Marginal Zone Lymphoma

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease.

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

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

Biospecimen Retention:   Samples With DNA
perpheral blood

Enrollment: 20
Actual Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

Inclusion Criteria:

Patients over the age of 18 years -

Exclusion Criteria:

Patients less than 18 years in age or mentally defectives.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01720758     History of Changes
Other Study ID Numbers: EMC-0124-11-CTIL
First Submitted: October 31, 2012
First Posted: November 2, 2012
Last Update Posted: August 11, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Leukemia, Hairy Cell
Lymphoproliferative Disorders
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia