CytopeniaBIOCEREVANCENCT04070612
National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.
An observational study of Cytopenia and Autoimmune Haemolytic Anaemia, run by University Hospital, Bordeaux.
Trial summary
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cytopenia, Autoimmune Haemolytic Anaemia, Thrombocytopenic Purpura, Immune
- What is being tested?
- Blood sample
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2007to 8 Jun 2012
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age strictly below 18 years of age at initial diagnosis
- Affiliate child or beneficiary of a social security scheme
- Child residing in metropolitan France
- Diagnosis of autoimmune haemolytic anemias, Evans syndrome and / or chronic Immune thrombocytopenic purpura
- Free, informed, written and signed consent
Who cannot join
- Diagnosis of constitutional haemolytic anemia
- Diagnosis of platelet constitutional disease
About this study
Official title: National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.
Read the detailed description
These autoimmune haematological diseases are rare diseases affecting the child, often very young, and serious and potentially life-threatening. International literature data are scarce, and include individual cases or small series.
They do not allow to determine an optimal therapeutic strategy in case of escape from the first-line treatments. Existing treatments (long-term corticosteroid therapy, immunoglobulins, splenectomy, immunosuppressants, chemotherapies, and more recently anti-CD20 antibodies) are inconsistently effective, and often associated with serious side effects.
The seriousness of these diseases, the therapeutic difficulties, and the absence of a targeted research project in France, led to the implementation of this study.
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.
- Being tested
- Blood sample
- Keywords
- Children
- Medical subject headings
- Cytopenia, Anemia, Hemolytic, Autoimmune, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
A blood sample of 2 times 2 to 5 ml additional maximum
| Study group | Role | What they receive |
|---|---|---|
| children with autoimmune haemolytic anemia | A blood sample of 2 times 2 to 5 ml additional maximum Receives: Other: Blood sample | |
| Children with Evans syndrome | A blood sample of 2 times 2 to 5 ml additional maximum Receives: Other: Blood sample | |
| Children with Immune thrombocytopenic purpura | A blood sample of 2 times 2 to 5 ml additional maximum Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete sustainable remission (yes/no) for children with autoimmune haemolytic anemias
Absence of clinical signs of anemia (grade 0) And Hemoglobin > 11 g / dl And reticulocytes <120,000 / mm3 And haptoglobin> 10 mg / dl And bilirubin <10 mg / l or 17 μmol / l And no specific treatment for at least 12 months
Measured: At the screening
complete remission (yes/no) for children with autoimmune haemolytic anemias
Absence of clinical signs of anemia (grade 0) And Hemoglobin> 11 g / dl And reticulocytes <120,000 / mm3 Regardless of the level of haptoglobin or bilirubin And specific treatment in progress or interrupted for less than 12 months
Measured: At the screening
partial remission (yes/no) for children with autoimmune haemolytic anemias
Clinical Signs of Anemia (Grade 1 or 2) Or Hemoglobin from 7 to 11 g / dl Or reticulocytes> 120,000 / mm3 Regardless of the level of haptoglobin or bilirubin
Measured: At the screening
no response (yes/no) for children with autoimmune haemolytic anemias
Clinical Signs of Severe Anemia (Grade 3 or More) Or Hemoglobin <7 g / dl
Measured: At the screening
deceased patient (yes/no) for children with autoimmune haemolytic anemias
Death yes/no
Measured: At the screening
Complete sustainable remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Absence of clinical signs of haemorrhage (grade 0) And platelets> 100,000 / mm3 And no specific treatment for at least 12 months
Measured: At the screening
complete remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Absence of clinical signs of haemorrhage (grade 0) And platelets> 100,000 / mm3 And specific treatment in progress or interrupted for less than 12 months
Measured: At the screening
partial remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Clinical Signs of Hemorrhage (Grade 1 or 2) Or platelets between 30,000 and 100,000 / mm3
Measured: At the screening
no response (yes/no) for children with chronic immunologic thrombocytopenic purpura
Clinical Signs of Severe Hemorrhage (Grade 3 or Greater) Or Platelets <30,000 / mm3
Measured: At the screening
deceased patient (yes/no) for children with chronic immunologic thrombocytopenic purpura
Death yes/no
Measured: At the screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start4 Apr 2007
- Primary completion8 Jun 2012
- Study completion8 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CytopeniaStudies 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
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves PEREL, Pr, Principal investigator, Bordeaux University Hsopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070612
- Sponsor's protocol ID
- CHUBX 2005/18
- Acronym
- BIOCEREVANCE
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glenet S, de Bisschop C, Delcambre F, Thiebaut R, Laurent F, Jougon J, Velly JF, Georges A, Guenard H. No compensatory lung growth after resection in a one-year follow-up cohort of patients with lung cancer. J Thorac Dis. 2017 Oct;9(10):3938-3945. doi: 10.21037/jtd.2017.08.135.
PubMed 29268404
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia
- ClinicalTrials.gov ID
- NCT04070612
- Acronym / sponsor ID
- BIOCEREVANCE / CHUBX 2005/18
- Keywords
- Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Apr 2007 (actual)
- Primary completion
- 8 Jun 2012 (actual)
- Study completion
- 8 Jun 2012 (actual)
- First posted
- 28 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.
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.
Detailed description
These autoimmune haematological diseases are rare diseases affecting the child, often very young, and serious and potentially life-threatening. International literature data are scarce, and include individual cases or small series.
They do not allow to determine an optimal therapeutic strategy in case of escape from the first-line treatments. Existing treatments (long-term corticosteroid therapy, immunoglobulins, splenectomy, immunosuppressants, chemotherapies, and more recently anti-CD20 antibodies) are inconsistently effective, and often associated with serious side effects.
The seriousness of these diseases, the therapeutic difficulties, and the absence of a targeted research project in France, led to the implementation of this study.
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children with autoimmune haemolytic anemia | – | Other: Blood sampleA blood sample of 2 times 2 to 5 ml additional maximum |
| Children with Evans syndrome | – | Other: Blood sampleA blood sample of 2 times 2 to 5 ml additional maximum |
| Children with Immune thrombocytopenic purpura | – | Other: Blood sampleA blood sample of 2 times 2 to 5 ml additional maximum |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age strictly below 18 years of age at initial diagnosis
- Affiliate child or beneficiary of a social security scheme
- Child residing in metropolitan France
- Diagnosis of autoimmune haemolytic anemias, Evans syndrome and / or chronic Immune thrombocytopenic purpura
- Free, informed, written and signed consent
Key exclusion criteria (2 listed)
- Diagnosis of constitutional haemolytic anemia
- Diagnosis of platelet constitutional disease
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 sampleA blood sample of 2 times 2 to 5 ml additional maximum | Other | Children with Evans syndrome, Children with Immune thrombocytopenic purpura, children with autoimmune haemolytic anemia |
Primary outcome
Complete sustainable remission (yes/no) for children with autoimmune haemolytic anemias
Time frame: At the screening
Absence of clinical signs of anemia (grade 0) And Hemoglobin > 11 g / dl And reticulocytes <120,000 / mm3 And haptoglobin> 10 mg / dl And bilirubin <10 mg / l or 17 μmol / l And no specific treatment for at least 12 months
complete remission (yes/no) for children with autoimmune haemolytic anemias
Time frame: At the screening
Absence of clinical signs of anemia (grade 0) And Hemoglobin> 11 g / dl And reticulocytes <120,000 / mm3 Regardless of the level of haptoglobin or bilirubin And specific treatment in progress or interrupted for less than 12 months
partial remission (yes/no) for children with autoimmune haemolytic anemias
Time frame: At the screening
Clinical Signs of Anemia (Grade 1 or 2) Or Hemoglobin from 7 to 11 g / dl Or reticulocytes> 120,000 / mm3 Regardless of the level of haptoglobin or bilirubin
no response (yes/no) for children with autoimmune haemolytic anemias
Time frame: At the screening
Clinical Signs of Severe Anemia (Grade 3 or More) Or Hemoglobin <7 g / dl
deceased patient (yes/no) for children with autoimmune haemolytic anemias
Time frame: At the screening
Death yes/no
Complete sustainable remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Time frame: At the screening
Absence of clinical signs of haemorrhage (grade 0) And platelets> 100,000 / mm3 And no specific treatment for at least 12 months
complete remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Time frame: At the screening
Absence of clinical signs of haemorrhage (grade 0) And platelets> 100,000 / mm3 And specific treatment in progress or interrupted for less than 12 months
partial remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Time frame: At the screening
Clinical Signs of Hemorrhage (Grade 1 or 2) Or platelets between 30,000 and 100,000 / mm3
no response (yes/no) for children with chronic immunologic thrombocytopenic purpura
Time frame: At the screening
Clinical Signs of Severe Hemorrhage (Grade 3 or Greater) Or Platelets <30,000 / mm3
deceased patient (yes/no) for children with chronic immunologic thrombocytopenic purpura
Time frame: At the screening
Death yes/no
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 18 Jun 2026.
- Results publication: PubMed 29268404Glenet S, de Bisschop C, Delcambre F, Thiebaut R, Laurent F, Jougon J, Velly JF, Georges A, Guenard H. No compensatory lung growth after resection in a one-year follow-up cohort of patients with lung cancer. J Thorac Dis. 2017 Oct;9(10):3938-3945. doi: 10.21037/jtd.2017.08.135.
- 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.
Yves PEREL, Pr principal investigator
Bordeaux University Hsopital
Questions about this trial
What is this clinical trial studying?
An observational study of Cytopenia and Autoimmune Haemolytic Anaemia, 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 5 inclusion and 2 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 18 Jun 2026. 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 sustainable remission (yes/no) for children with autoimmune haemolytic anemias (time frame: At the screening). The study lists 10 primary outcomes in all. 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 NCT04070612, which also lists 1 linked publication.
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 18 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.