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Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04889573
Acronym
R2IGH
Enrollment
120
Registered
2021-05-17
Start date
2021-07-07
Completion date
2021-10-14
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

B-cells, BCR, VDJ rearrangement, SHM, CSR, LSR, Ig, HTS, normal values

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.

Interventions

GENETICBlood sample

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Frequency of use of the V, D and J genes in VDJ rearrangementsthrough study completion, an average of 18 months

Secondary

MeasureTime frameDescription
Percentage of HyperMutation Somatic (SHM) in VDJ regionsthrough study completion, an average of 18 months
Nature of HyperMutation Somatic (SHM)through study completion, an average of 18 monthstransitions and transversions
Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctionsthrough study completion, an average of 18 monthsnumber of CSR and LSR junctions
Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctionsthrough study completion, an average of 18 monthsfrequency of CSR and LSR junctions according to their structure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026