ThrombocytopeniaICTUSNCT04003220
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
An observational study of Thrombocytopenia and Purpura, Thrombocytopenic, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopenia, Purpura, Thrombocytopenic, Myelodysplastic Syndromes
- What is being tested?
- blood sample and Bone marrow sample
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Sep 2020to 7 Sep 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this project we will study 30 patients with ICTUS, 20 ITP with immunological features, 20 MDS patients and 10 Healthy volunteers (normal bone marrow donors, obtained during a sternotomy performed in the cardiac surgery unit).
Who may be able to join
- Age: 18-80
- Nosological criteria for thrombocytopenic patients:
- ICTUS: acquired thrombocytopenia lasting>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration.
- ITP: Diagnosis of ITP is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia. There is no "gold standard" test that can reliably establish the diagnosis. We are concerned that this group of patients may include ICTUS patients.
- ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab) and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will use these patients as non-ICTUS, ITP positive controls.
- Thrombocytopenic myelodysplasia: platelets <150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).
- Healthy controls: patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors.
- Affiliated person or beneficiary of a social security scheme. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- Age under 18 or over 80
- Persons placed under judicial protection,
- Persons participating in another research including a period of exclusion still in course
- Persons in emergency situation,
- Pregnant or nursing women,
- Women of childbearing age who do not benefit from effective contraception (HAS criteria),
- Brain death or deceased persons,
- Person who doesn't speak French, doesn't read it, doesn't write it, and doesn't have a schooling in France.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Immunopathologie Clinique - Hôpital Saint Louis - AP HP
Paris, 75010
Lionel GALICIER, MD, +331.42.49.96.90, lionel.galicier@aphp.fr
Lionel GALICIER, MD
- Recruiting
Chirurgie cardiaque - Hôpital Haut Lévêque - CHU de Bordeaux
Pessac, 33600
Mathieu PERNOT, MD, +335.57.65.69.69, mathieu.pernot@chu-bordeaux.fr
Mathieu PERNOT, MD
- Recruiting
Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan
Pessac, 33600
Noel MILPIED, noel.milpied@chu-bordeaux.fr
Krimo BOUABDALLAH
- Recruiting
service de médecine interne et maladies infectieuses - Groupe hospitalier Sud
Pessac
Jean-François VIALLARD, Prof, jean-francois.viallard@chu-bordeaux.fr
Jean-François VIALLARD, Prof
About this study
It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia
Read the detailed description
This study is a prospective study to collect blood, bone marrow and hair bulb from patients with thrombocytopenia, to better understand the mechanism of idiopathic chronic thrombocytopenia of undetermined significance (ICTUS)
- Being tested
- blood sample, Bone marrow sample
- Medical subject headings
- Thrombocytopenia, Purpura, Thrombocytopenic, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
The extra samples will be taken Blood sampling
Bone marrow sampleProcedure or surgery
This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls
| Study group | Role | What they receive |
|---|---|---|
| MyeloDysplastic Syndrome | platelets <150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features). Receives: Procedure: blood sample | |
| Idiopathic Chronic Thrombocytopenia of Unknown Significance | Acquired thrombocytopenia lasting>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration. Receives: Procedure: blood sample; Procedure: Bone marrow sample | |
| Immune Thrombocytopenic Purpura | Diagnosis of Immune Thrombocytopenic Purpura (ITP) is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia Receives: Procedure: blood sample | |
| healthy volunteers undergoing cardiac surgery | patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors Receives: Procedure: Bone marrow sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of clonality in patients with ICTUS
identification of mutations in genes known to be involved in clonal expansion
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start7 Sep 2020
- Primary completion7 Sep 2023 (estimated)
- Study completion7 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JAMES, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003220
- Sponsor's protocol ID
- CHUBX 2018/47
- Acronym
- ICTUS
- Status last verified
- Nov 2022
- First submitted
- 26 Jun 2019
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
- ClinicalTrials.gov ID
- NCT04003220
- Acronym / sponsor ID
- ICTUS / CHUBX 2018/47
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 7 Sep 2023 (estimated)
- Study completion
- 7 Sep 2023 (estimated)
- First posted
- 1 Jul 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.
It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia
Detailed description
This study is a prospective study to collect blood, bone marrow and hair bulb from patients with thrombocytopenia, to better understand the mechanism of idiopathic chronic thrombocytopenia of undetermined significance (ICTUS)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MyeloDysplastic Syndrome | – | Procedure: blood sampleplatelets <150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features). |
| Idiopathic Chronic Thrombocytopenia of Unknown Significance | – | Procedure: blood sample, Procedure: Bone marrow sampleAcquired thrombocytopenia lasting>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration. |
| Immune Thrombocytopenic Purpura | – | Procedure: blood sampleDiagnosis of Immune Thrombocytopenic Purpura (ITP) is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia |
| healthy volunteers undergoing cardiac surgery | – | Procedure: Bone marrow samplepatients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this project we will study 30 patients with ICTUS, 20 ITP with immunological features, 20 MDS patients and 10 Healthy volunteers (normal bone marrow donors, obtained during a sternotomy performed in the cardiac surgery unit).
Key inclusion criteria (8 listed)
- Age: 18-80
- Nosological criteria for thrombocytopenic patients:
- ICTUS: acquired thrombocytopenia lasting>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration.
- ITP: Diagnosis of ITP is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia. There is no "gold standard" test that can reliably establish the diagnosis. We are concerned that this group of patients may include ICTUS patients.
- ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab) and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will use these patients as non-ICTUS, ITP positive controls.
Key exclusion criteria (8 listed)
- Age under 18 or over 80
- Persons placed under judicial protection,
- Persons participating in another research including a period of exclusion still in course
- Persons in emergency situation,
- Pregnant or nursing women,
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 extra samples will be taken Blood sampling | Procedure or surgery | Idiopathic Chronic Thrombocytopenia of Unknown Significance, Immune Thrombocytopenic Purpura, MyeloDysplastic Syndrome |
| Bone marrow sampleThis bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls | Procedure or surgery | Idiopathic Chronic Thrombocytopenia of Unknown Significance, healthy volunteers undergoing cardiac surgery |
Primary outcome
Measure of clonality in patients with ICTUS
Time frame: Day 1
identification of mutations in genes known to be involved in clonal expansion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- 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.
JAMES, MD, PhD principal investigator
University Hospital, Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Purpura, Thrombocytopenic, run by University Hospital, Bordeaux at 4 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloé JAMES, MD,PhD (+335 57 65 64 78, chloe.james@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of clonality in patients with ICTUS (time frame: Day 1). 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 28 Nov 2022.