NCT04889573

Brief Summary

B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

May 5, 2021

Last Update Submit

July 28, 2025

Conditions

Healthy Volunteers

Keywords

B-cellsBCRVDJ rearrangementSHMCSRLSRIgHTSnormal values

Outcome Measures

Primary Outcomes (1)

  • Frequency of use of the V, D and J genes in VDJ rearrangements

    through study completion, an average of 18 months

Secondary Outcomes (4)

  • Percentage of HyperMutation Somatic (SHM) in VDJ regions

    through study completion, an average of 18 months

  • Nature of HyperMutation Somatic (SHM)

    through study completion, an average of 18 months

  • Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions

    through study completion, an average of 18 months

  • Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions

    through study completion, an average of 18 months

Study Arms (1)

Blood sample

EXPERIMENTAL
Genetic: Blood sample

Interventions

Blood sampleGENETIC

The blood samples will be collected from healthy volunteers : 7 tubes of 7 ml with anti-coagulant Héparine Lithium and 1 tube of 7ml with anti-coagulant EDTA

Blood sample

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers aged between 18 and 70
  • volunteers free from lymphoid hemopathy, immune deficiency and autoimmune disease.
  • categories : volunteers between 18 and 34 years of age, volunteers between 35 and 50 years of age, volunteers between 51 and 69 years of age.

You may not qualify if:

  • any recent vaccination (\< 4 weeks)
  • tumoral pathology
  • lymphoïd hemopathy
  • immune deficiency
  • autoimmune disease
  • transplanted patients
  • inflammatory / systemic diseases
  • hypersensitivity or allergies
  • treatments likely to modify the immune response :
  • calcineurin inhibitors: ciclosporin, tacrolimus -antimetabolite: azathioprine, mycophenolate mofetil / mycophenolic acid, 6-mercaptopurine, methotrexate
  • cyclophosphamide
  • antilymphocyte serum (rabbit, horse)
  • mTOR inhibitors: everolimus, sirolimus
  • anti-CD25 (anti IL2-R): basiliximab, dacliximab -belatacept (anti CD80-86)
  • abatacept (CTLA4-Ig)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hospital

Limoges, 87200, France

Location

Related Publications (1)

  • Al Jamal I, Parquet M, Guiyedi K, Aoufouchi S, Le Guillou M, Rizzo D, Pollet J, Dupont M, Boulin M, Faumont N, Boutouil H, Jardin F, Ruminy P, El Hamel C, Lerat J, Al Hamaoui S, Makdissy N, Feuillard J, Gachard N, Peron S. IGH 3'RR recombination uncovers a non-germinal center imprint and c-MYC-dependent IGH rearrangement in unmutated chronic lymphocytic leukemia. Haematologica. 2024 Feb 1;109(2):466-478. doi: 10.3324/haematol.2023.282897.

    PMID: 37496419BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 17, 2021

Study Start

July 7, 2021

Primary Completion

October 14, 2021

Study Completion

October 14, 2021

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)