Purpura, Thrombocytopenic, IdiopathicPTIREGNCT02891109
Regulatory B Cells and Chronic Immune Thrombocytopenia
An observational study of Purpura, Thrombocytopenic, Idiopathic and Regulatory B Cells, run by University Hospital, Brest at 1 site in France.
Trial summary
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic, Regulatory B Cells
- What is being tested?
- Biological tests
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Sep 2015
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with a Purpura, Thrombocytopenic, Idiopathic, in chronic phase (>12 months) and healthy volunteers as control residents in Brest town, France.
Who may be able to join
- Purpura, Thrombocytopenic, Idiopathic, chronic phase (>12 months)
- no treatment or thrombopoietin receptor agonists
Who cannot join
- < 18 years
- Purpura, Thrombocytopenic, Idiopathic, acute phase
- pregnancy
- others causes of thrombopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.
Read the detailed description
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.
- Being tested
- Biological tests
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological testsBiological
From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| patients group | Adults patients with chronic immune thrombocytopenia Receives: Biological: Biological tests | |
| control group | Adults without immune thrombocytopenia Receives: Biological: Biological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulatory B cells functionality
inhibition of T cells proliferation with co-culture B and T cells
Measured: 1 week
Secondary outcomes (1)
Cytometry immunophenotyping of B and T cells
characterization of B and T cells by flow cytometry
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Thrombocytopenic, IdiopathicStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Jamin, PhD, Principal investigator, CHRU de BrestLenaig Le Clech, MD, Principal investigator, CHRU BRESTBrigitte Pan-Petesh, MD, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891109
- Sponsor's protocol ID
- PTIREG
- Acronym
- PTIREG
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT02891109
- Acronym / sponsor ID
- PTIREG / PTIREG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.
Detailed description
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients group | – | Biological: Biological testsAdults patients with chronic immune thrombocytopenia |
| control group | – | Biological: Biological testsAdults without immune thrombocytopenia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a Purpura, Thrombocytopenic, Idiopathic, in chronic phase (>12 months) and healthy volunteers as control residents in Brest town, France.
Key inclusion criteria (2 listed)
- Purpura, Thrombocytopenic, Idiopathic, chronic phase (>12 months)
- no treatment or thrombopoietin receptor agonists
Key exclusion criteria (4 listed)
- < 18 years
- Purpura, Thrombocytopenic, Idiopathic, acute phase
- pregnancy
- others causes of thrombopenia
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 |
|---|---|---|
| Biological testsFrom the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry | Biological | control group, patients group |
Primary outcome
Regulatory B cells functionality
Time frame: 1 week
inhibition of T cells proliferation with co-culture B and T cells
1 secondary outcome
Cytometry immunophenotyping of B and T cells
Time frame: 1 week
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 7 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Christophe Jamin, PhD principal investigator
CHRU de Brest
Lenaig Le Clech, MD principal investigator
CHRU BREST
Brigitte Pan-Petesh, MD principal investigator
CHRU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Purpura, Thrombocytopenic, Idiopathic and Regulatory B Cells, run by University Hospital, Brest 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 2 inclusion and 4 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 7 Sep 2016. 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?
Regulatory B cells functionality (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2016.