Skip to main content
OpenTrials
Completed

NCT Number: NCT04889573

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges University Hospital

Limoges, 87200, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers aged between 18 and 70
  • volunteers free from lymphoid hemopathy, immune deficiency and autoimmune disease.

3 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.

Exclusion criteria

  • 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)
  • OKT3 (Muronomab-CD3, anti-CD23)
  • glucocorticoids: methylprednisolone, prednisone, prednisolone.
  • entuzumab (anti-CD52)
  • rituximab, ocrelizumab (anti-CD20)
  • eculizumab (anti-C5)
  • anakinra (analogue IL1-RA)
  • leflunomide (dihydroorotate dehydrogenase inhibition)
  • bortezomib (proteasome inhibitor)
  • fingolimod (S1P receptor antagonist)
  • alentuzumab (anti CD52)
  • Ig G -antiTNF (etanercept, infliximab, adalimumab, certolizumab)
  • vedolizumab (Anti-integrin α4β7 Ab)
  • ustekinumab (anti-IL12)
  • natalizumab (anti-integrin a4)
  • mitoxantrone (topoisomerase type II inhibitor)
  • tocilizumab (anti-IL6)

Treatment and study plan

blood sample

Genetic

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

Primary outcomes

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

    Time frame: through study completion, an average of 18 months

Secondary outcomes

  1. Percentage of HyperMutation Somatic (SHM) in VDJ regions

    Time frame: through study completion, an average of 18 months

  2. Nature of HyperMutation Somatic (SHM)

    Time frame: through study completion, an average of 18 months

    transitions and transversions

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

    Time frame: through study completion, an average of 18 months

    number of CSR and LSR junctions

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

    Time frame: through study completion, an average of 18 months

    frequency of CSR and LSR junctions according to their structure

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: R2IGH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Jul 30, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.