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OpenTrials
Completed

NCT Number: NCT02640287

Expression of Ku70/XRCC6 in Waldenström's Macroglobulinemia

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.

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Key information

Conditions

Waldenström Macroglobulinemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood or bone marrow samples

Biological

Primary outcomes

  1. Measure of ratio Ku70/XRCC6

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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.

Acronym: WAL-KU

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 28, 2015
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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