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

This study is not yet open for participant recruitment.
Verified October 2012 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01720758
First received: October 31, 2012
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  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: Time Perspective: Prospective
Official Title: Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Lymphoma
U.S. FDA Resources

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

Primary Outcome Measures:
  • detection of the B-RAF V600E mutation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

perpheral blood


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720758

Contacts
Contact: Michael Bennett, MB BS FRCP FRCPath 972 46494247 benet_m@clalit.org.il

Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01720758     History of Changes
Other Study ID Numbers: EMC-0124-11-CTIL
Study First Received: October 31, 2012
Last Updated: November 1, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013