Back to resultsExpression of Ku70/XRCC6 in Waldenström's Macroglobulinemia (WAL-KU)
Primary Purpose
Waldenström Macroglobulinemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood or bone marrow samples
Sponsored by
About this trial
This is an interventional other trial for Waldenström Macroglobulinemia
Eligibility Criteria
Inclusion Criteria:
- Patient over 18 years, affiliated to the social regimen
- Written consent collected
MW group :
- Patient with a diagnosis of MW according to WHO criteria (based on the results of serum protein electrophoresis, bone marrow analysis with immunophenotyping, cytogenetic analysis and mutation L265P MyD88)
Other SLP :
- Patient with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma
Healthy volunteers :
- volunteers without blood disorders
Exclusion Criteria:
- Women of childbearing age who do not have an effective means of contraception
- Pregnant or nursing
- Demonstration of a kappa or lambda monotype on B lymphocytes
- healthy volunteer with B-cell malignancy
Sites / Locations
- CHRU Nancy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Waldenström macroglobulinemia
Others B-cell malignancies
Healthy subjects
Arm Description
Patients with diagnosis of Waldenström macroglobulinemia
Patients with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma
Control healthy subjects without B-cell malignancy
Outcomes
Primary Outcome Measures
Measure of ratio Ku70/XRCC6
Comparing the average level of expression of Ku70 in B cells measured in patients of WM, in patients other SLP and in healthy subjects (without MW and other SLP) , matched for age ( +/- 5 years) and sex
Secondary Outcome Measures
Full Information
NCT ID
NCT02640287
First Posted
December 22, 2015
Last Updated
August 1, 2021
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02640287
Brief Title
Expression of Ku70/XRCC6 in Waldenström's Macroglobulinemia
Acronym
WAL-KU
Official Title
Expression of Ku70/XRCC6 and Others NHEJ Components in Waldenström's Macroglobulinemia in Comparison With Others B-cell Lymphoproliferative Disorders and Normal B Cells.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present poorly understood, although a recurrent mutation (L265P MYD88) has recently been described. Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group showed that MW had a specific proteomic profile, and one of the differentially expressed proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .
The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic or epigenetic modification) in comparison with other lymphoid malignancies and normal B cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenström Macroglobulinemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Waldenström macroglobulinemia
Arm Type
Experimental
Arm Description
Patients with diagnosis of Waldenström macroglobulinemia
Arm Title
Others B-cell malignancies
Arm Type
Experimental
Arm Description
Patients with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
Control healthy subjects without B-cell malignancy
Intervention Type
Biological
Intervention Name(s)
Blood or bone marrow samples
Primary Outcome Measure Information:
Title
Measure of ratio Ku70/XRCC6
Description
Comparing the average level of expression of Ku70 in B cells measured in patients of WM, in patients other SLP and in healthy subjects (without MW and other SLP) , matched for age ( +/- 5 years) and sex
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient over 18 years, affiliated to the social regimen
Written consent collected
MW group :
Patient with a diagnosis of MW according to WHO criteria (based on the results of serum protein electrophoresis, bone marrow analysis with immunophenotyping, cytogenetic analysis and mutation L265P MyD88)
Other SLP :
Patient with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma
Healthy volunteers :
volunteers without blood disorders
Exclusion Criteria:
Women of childbearing age who do not have an effective means of contraception
Pregnant or nursing
Demonstration of a kappa or lambda monotype on B lymphocytes
healthy volunteer with B-cell malignancy
Facility Information:
Facility Name
CHRU Nancy
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Expression of Ku70/XRCC6 in Waldenström's Macroglobulinemia
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