Idiopathic Thrombocytopenic PurpuraSYMPATHICNCT03421392
Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT
An observational study of Idiopathic Thrombocytopenic Purpura, run by Nantes University Hospital at 1 site in France.
Trial summary
Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- non interventional study
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Nov 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 3 Populations will be recruited in the study: Number of topics planned: 50 Patients in the PTI group 50 patients in the non-immunological thrombocytopenia group 50 patients in the control group
Who may be able to join
- Adult patients (>18yo) with a diagnosis of ITP (primary acute, persisting or chronical)
- Adult patients (>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia)
- Adult patients (>18 yo) without thrombocytopenia
- Enrolled in a Social Security system
- Having provided informed consent
Who cannot join
- Minor patients (<18 yo)
- Enrolled in another clinical study
- Having received corticosteroids or polyvalent immunoglobulins in the past 4
- weeks or anti-platelet therapy or NSAID during the past 7 days
- Having received platelet transfusion in the past fortnight
- With proven iron deficiency
Show all 9Show fewer
- With drug-induced immune-allergic thrombocytopenia.
- Pregnant and breastfeeding women,
- guardian patients, will be excluded from this population.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.
Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.
Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- non interventional study
- Keywords
- constitutive thrombocytopenia, central thrombocytopenia, platelets, sialylation, flow cytometry
- 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.
non interventional studyOther
non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic thrombocytopenic purpura | Not described Receives: Other: non interventional study | |
| non immunological thrombocytopenia | patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia Receives: Other: non interventional study | |
| without thrombocytopenia | Not described Receives: Other: non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls
a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin
Measured: 18 months
Secondary outcomes (1)
Prognostic value and therapy
prognostic value of the level of sialylation in ITP patients regarding disease evolution and response of first line treatments and splenectomy.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jan 2018
- Primary completion23 Oct 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fouassier, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421392
- Sponsor's protocol ID
- RC17_0346
- Acronym
- SYMPATHIC
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, van der Wal DE, Zhu G, Xu M, Yougbare I, Ma L, Vadasz B, Carrim N, Grozovsky R, Ruan M, Zhu L, Zeng Q, Tao L, Zhai ZM, Peng J, Hou M, Leytin V, Freedman J, Hoffmeister KM, Ni H. Desialylation is a mechanism of Fc-independent platelet clearance and a therapeutic target in immune thrombocytopenia. Nat Commun. 2015 Jul 17;6:7737. doi: 10.1038/ncomms8737.
PubMed 26185093Sorensen AL, Rumjantseva V, Nayeb-Hashemi S, Clausen H, Hartwig JH, Wandall HH, Hoffmeister KM. Role of sialic acid for platelet life span: exposure of beta-galactose results in the rapid clearance of platelets from the circulation by asialoglycoprotein receptor-expressing liver macrophages and hepatocytes. Blood. 2009 Aug 20;114(8):1645-54. doi: 10.1182/blood-2009-01-199414. Epub 2009 Jun 11.
PubMed 19520807
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.
- ClinicalTrials.gov ID
- NCT03421392
- Acronym / sponsor ID
- SYMPATHIC / RC17_0346
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- constitutive thrombocytopenia, central thrombocytopenia, platelets, sialylation, flow cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 5 Feb 2018 (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.
Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.
Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Idiopathic thrombocytopenic purpura | – | Other: non interventional study |
| non immunological thrombocytopenia | – | Other: non interventional studypatient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia |
| without thrombocytopenia | – | Other: non interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 Populations will be recruited in the study: Number of topics planned: 50 Patients in the PTI group 50 patients in the non-immunological thrombocytopenia group 50 patients in the control group
Key inclusion criteria (5 listed)
- Adult patients (>18yo) with a diagnosis of ITP (primary acute, persisting or chronical)
- Adult patients (>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia)
- Adult patients (>18 yo) without thrombocytopenia
- Enrolled in a Social Security system
- Having provided informed consent
Key exclusion criteria (9 listed)
- Minor patients (<18 yo)
- Enrolled in another clinical study
- Having received corticosteroids or polyvalent immunoglobulins in the past 4
- weeks or anti-platelet therapy or NSAID during the past 7 days
- Having received platelet transfusion in the past fortnight
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 |
|---|---|---|
| non interventional studynon interventional study | Other | Idiopathic thrombocytopenic purpura, non immunological thrombocytopenia, without thrombocytopenia |
Primary outcome
Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls
Time frame: 18 months
a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin
1 secondary outcome
Prognostic value and therapy
Time frame: 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 1 Feb 2022.
- Background: PubMed 26185093Li J, van der Wal DE, Zhu G, Xu M, Yougbare I, Ma L, Vadasz B, Carrim N, Grozovsky R, Ruan M, Zhu L, Zeng Q, Tao L, Zhai ZM, Peng J, Hou M, Leytin V, Freedman J, Hoffmeister KM, Ni H. Desialylation is a mechanism of Fc-independent platelet clearance and a therapeutic target in immune thrombocytopenia. Nat Commun. 2015 Jul 17;6:7737. doi: 10.1038/ncomms8737.
- Background: PubMed 19520807Sorensen AL, Rumjantseva V, Nayeb-Hashemi S, Clausen H, Hartwig JH, Wandall HH, Hoffmeister KM. Role of sialic acid for platelet life span: exposure of beta-galactose results in the rapid clearance of platelets from the circulation by asialoglycoprotein receptor-expressing liver macrophages and hepatocytes. Blood. 2009 Aug 20;114(8):1645-54. doi: 10.1182/blood-2009-01-199414. Epub 2009 Jun 11.
- 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.
Marc Fouassier, Dr principal investigator
Nantes University Hospital
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 Idiopathic Thrombocytopenic Purpura, run by Nantes University Hospital 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 5 inclusion and 9 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 1 Feb 2022. 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?
Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls (time frame: 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 NCT03421392, which also lists 2 linked publications.
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 1 Feb 2022.