Immune Thrombocytopenic PurpuraSPLENOTIRNCT04056507
Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura
An observational study of Immune Thrombocytopenic Purpura and Splenectomy; Status, run by University Hospital, Bordeaux.
Trial summary
The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immune Thrombocytopenic Purpura, Splenectomy; Status
- What is being tested?
- Immunolabeling
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2012to 30 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Spleens come from patients with ITP (defined as thrombocytopenia <100 G / L) after an infectious, drug, autoimmune disease, hematological malignancy or immunodeficiency cause has been eliminated. Rodeghiero, 2009) who received a splenectomy to treat their condition in the department of Professor JL Pellegrin.
Who may be able to join
- The analyzed spleens belong to the collection of biological samples declared to the ministry by the Laboratory of Pathology of Haut-Lévêque Hospital (Dr Parrens).
Who cannot join
- Opposition of the patient.
About this study
Official title: Retrospective Study of Splenic Immunological Markers as Predictive Factors for Response to Splenectomy in Adult Patients Affected by a Immune Thrombocytopenic Purpura
The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura).
Read the detailed description
Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (<3 months), persistent ITP (3-12 months) and chronic ITP (> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.
The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.
At present, no predictive factor of splenectomy success has been identified. The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP.
- Being tested
- Immunolabeling
- Keywords
- Immunological parameters, Histological parameters
- 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.
ImmunolabelingProcedure or surgery
Immunolabeling of abnormalities observed by the cell study in flow cytometry.
| Study group | Role | What they receive |
|---|---|---|
| ITP group | On frozen spleens of already splenectomized adult ITP patients. Receives: Procedure: Immunolabeling | |
| Control group | On frozen control spleens from patients who had a splenectomy at the Bordeaux University Hospital following a road accident. Receives: Procedure: Immunolabeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) after splenectomy.
Determination of ITP status following Rodeghiero criteria : complete remission if platelet count > 100 G/L. patient who is not on complete remission after splenectomy will be considered to be failing.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start12 Apr 2012
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François VIALLARD, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056507
- Sponsor's protocol ID
- CHU BX 2011/05
- Acronym
- SPLENOTIR
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Splenic Immunological Markers as Predictive Factors for Response to Splenectomy in Adult Patients Affected by a Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT04056507
- Acronym / sponsor ID
- SPLENOTIR / CHU BX 2011/05
- Keywords
- Immunological parameters, Histological parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Apr 2012 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 14 Aug 2019 (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.
The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura).
Detailed description
Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (<3 months), persistent ITP (3-12 months) and chronic ITP (> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.
The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.
At present, no predictive factor of splenectomy success has been identified. The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITP group | – | Procedure: ImmunolabelingOn frozen spleens of already splenectomized adult ITP patients. |
| Control group | – | Procedure: ImmunolabelingOn frozen control spleens from patients who had a splenectomy at the Bordeaux University Hospital following a road accident. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spleens come from patients with ITP (defined as thrombocytopenia <100 G / L) after an infectious, drug, autoimmune disease, hematological malignancy or immunodeficiency cause has been eliminated. Rodeghiero, 2009) who received a splenectomy to treat their condition in the department of Professor JL Pellegrin.
Key inclusion criteria (1 listed)
- The analyzed spleens belong to the collection of biological samples declared to the ministry by the Laboratory of Pathology of Haut-Lévêque Hospital (Dr Parrens).
Key exclusion criteria (1 listed)
- Opposition of the patient.
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 |
|---|---|---|
| ImmunolabelingImmunolabeling of abnormalities observed by the cell study in flow cytometry. | Procedure or surgery | Control group, ITP group |
Primary outcome
Complete remission (CR) after splenectomy.
Time frame: At the inclusion
Determination of ITP status following Rodeghiero criteria : complete remission if platelet count > 100 G/L. patient who is not on complete remission after splenectomy will be considered to be failing.
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 14 Aug 2019.
Related trials for Immune Thrombocytopenic Purpura
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
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.
Jean-François VIALLARD, Pr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenic Purpura and Splenectomy; Status, run by University Hospital, Bordeaux.
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 1 inclusion and 1 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Complete remission (CR) after splenectomy. (time frame: At the inclusion). 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 14 Aug 2019.