Expression of Ku70/XRCC6 in Waldenström's Macroglobulinemia

Waldenström Macroglobulinemia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640287
• Other study ID #: 2015-A01516-43
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Biological:
• Blood or bone marrow samples

Locations

Country	Name	City	State
France	CHRU Nancy	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline