Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

NCT ID: NCT04889573

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2021-10-14

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blood sample

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: 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

Interventions

Blood 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

Intervention Type: GENETIC

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Limoges University Hospital

Limoges, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37496419 (View on PubMed)

Other Identifiers

87RI20_0074 (R2IGH)

Identifier Type: -

Identifier Source: org_study_id