Healthy VolunteersR2IGHNCT04889573
Immunoglobulin Gene Rearrangement and Repair in Healthy Donors
A study testing Blood sample in people with Healthy Volunteers, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2021to 14 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any recent vaccination (< 4 weeks)
- tumoral pathology
- lymphoïd hemopathy
- immune deficiency
- autoimmune disease
- transplanted patients
Show all 31Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Blood sample
- Keywords
- B-cells, BCR, VDJ rearrangement, SHM, CSR, LSR, Ig, HTS, normal values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Experimental | Not described Receives: Genetic: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of use of the V, D and J genes in VDJ rearrangements
Measured: through study completion, an average of 18 months
Secondary outcomes (4)
Percentage of HyperMutation Somatic (SHM) in VDJ regions
Measured: through study completion, an average of 18 months
Nature of HyperMutation Somatic (SHM)
transitions and transversions
Measured: through study completion, an average of 18 months
Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions
number of CSR and LSR junctions
Measured: through study completion, an average of 18 months
Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions
frequency of CSR and LSR junctions according to their structure
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start7 Jul 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889573
- Sponsor's protocol ID
- 87RI20_0074 (R2IGH)
- Acronym
- R2IGH
- Status last verified
- Jul 2025
- First submitted
- 5 May 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37496419
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoglobulin Gene Rearrangement and Repair in Healthy Donors
- ClinicalTrials.gov ID
- NCT04889573
- Acronym / sponsor ID
- R2IGH / 87RI20_0074 (R2IGH)
- Conditions
- Healthy Volunteers
- Keywords
- B-cells, BCR, VDJ rearrangement, SHM, CSR, LSR, Ig, HTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Experimental | Genetic: Blood sample |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (31 listed)
- any recent vaccination (< 4 weeks)
- tumoral pathology
- lymphoïd hemopathy
- immune deficiency
- autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleThe 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 | Genetic | Blood sample |
Primary outcome
Frequency of use of the V, D and J genes in VDJ rearrangements
Time frame: through study completion, an average of 18 months
4 secondary outcomes
Percentage of HyperMutation Somatic (SHM) in VDJ regions
Time frame: through study completion, an average of 18 months
Nature of HyperMutation Somatic (SHM)
Time frame: through study completion, an average of 18 months
Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions
Time frame: through study completion, an average of 18 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Results publication: PubMed 37496419Al 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Healthy Volunteers, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of use of the V, D and J genes in VDJ rearrangements (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.