Immunoglobulin Gene Rearrangement and Repair in Healthy Donors (NCT04889573) | Clinical Trial Compass
CompletedNot Applicable
Immunoglobulin Gene Rearrangement and Repair in Healthy Donors
France120 participantsStarted 2021-07-07
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-int…
What they're measuring
1
Frequency of use of the V, D and J genes in VDJ rearrangements
Timeframe: through study completion, an average of 18 months