NCT02640287

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

4.3 years

First QC Date

December 22, 2015

Last Update Submit

August 1, 2021

Conditions

Waldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Waldenström macroglobulinemia

EXPERIMENTAL

Patients with diagnosis of Waldenström macroglobulinemia

Biological: Blood or bone marrow samples

Others B-cell malignancies

EXPERIMENTAL

Patients with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma

Biological: Blood or bone marrow samples

Healthy subjects

OTHER

Control healthy subjects without B-cell malignancy

Biological: Blood or bone marrow samples

Interventions

Blood or bone marrow samplesBIOLOGICAL
Healthy subjectsOthers B-cell malignanciesWaldenström macroglobulinemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 28, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)