Primary Immune Thrombocytopenia (ITP)PTI PARINCT02042560
Study of Immune Thrombocytopenia Pathogenesis:
An observational study of Primary Immune Thrombocytopenia (ITP), run by Centre Hospitalier Universitaire Dijon at 3 sites in France.
Trial summary
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- Blood samples and Spleen samples
- How many people
- 89 participants
- Where
- 3 sitesFrance
- Study dates
- 4 May 2011to 12 Mar 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 ITP
Who may be able to join
- Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
- persons who have provided written informed consent
Who cannot join
- persons without national health insurance
- persons under 18 years old
- patients under guardianship
- pregnancy
- subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Besançon
Besançon, 25000
CHU de Dijon
Dijon, 21079
CHU de METZ
Metz, 57000
About this study
Official title: Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.
The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Being tested
- Blood samples, Spleen samples
- 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.
Blood samplesOther
Spleen samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with ITP | Not described Receives: Other: Blood samples; Other: Spleen samples | |
| Controls | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood level T cell in ITP patients and in healthy controls
Measured: baseline
blood level T cell in ITP patients after treatments
Measured: change from baseline at 4 to 8 weeks
Secondary outcomes (3)
blood level splenic T cell in ITP patients and in healthy controls
Measured: baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls
Measured: through study completion, an average of 3 years
level of T follicular helper cell
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start4 May 2011
- Primary completion12 Mar 2015
- Study completion12 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042560
- Sponsor's protocol ID
- LORCERIE PARI 2010
- Acronym
- PTI PARI
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2014
- Last updated
- 15 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.
- ClinicalTrials.gov ID
- NCT02042560
- Acronym / sponsor ID
- PTI PARI / LORCERIE PARI 2010
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 4 May 2011 (actual)
- Primary completion
- 12 Mar 2015 (actual)
- Study completion
- 12 Mar 2015 (actual)
- First posted
- 23 Jan 2014 (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.
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.
The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ITP | – | Other: Blood samples, Other: Spleen samples |
| Controls | – | Other: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ITP
Key inclusion criteria (2 listed)
- Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
- persons who have provided written informed consent
Key exclusion criteria (5 listed)
- persons without national health insurance
- persons under 18 years old
- patients under guardianship
- pregnancy
- subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
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 samples | Other | Controls, Patients with ITP |
| Spleen samples | Other | Patients with ITP |
Primary outcome
blood level T cell in ITP patients and in healthy controls
Time frame: baseline
blood level T cell in ITP patients after treatments
Time frame: change from baseline at 4 to 8 weeks
3 secondary outcomes
blood level splenic T cell in ITP patients and in healthy controls
Time frame: baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls
Time frame: through study completion, an average of 3 years
level of T follicular helper cell
Time frame: through study completion, an average of 3 years
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 15 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Thrombocytopenia (ITP), run by Centre Hospitalier Universitaire Dijon at 3 sites 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 5 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 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
blood level T cell in ITP patients and in healthy controls (time frame: baseline). The study lists 2 primary outcomes in all. 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 15 Mar 2018.