NCT01720758

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

October 31, 2012

Last Update Submit

August 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • detection of the B-RAF V600E mutation

    2 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients over the age of 18 years -

You may not qualify if:

  • Patients less than 18 years in age or mentally defectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

perpheral blood

MeSH Terms

Conditions

Leukemia, Hairy Cell

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 2, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

August 11, 2017

Record last verified: 2017-08