National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia. (BIOCEREVANCE)
National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosis of constitutional haemolytic anemia
- Diagnosis of platelet constitutional disease
研究計画
研究はどのように設計されていますか?
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
children with autoimmune haemolytic anemia
A blood sample of 2 times 2 to 5 ml additional maximum
|
A blood sample of 2 times 2 to 5 ml additional maximum
|
Children with Evans syndrome
A blood sample of 2 times 2 to 5 ml additional maximum
|
A blood sample of 2 times 2 to 5 ml additional maximum
|
Children with Immune thrombocytopenic purpura
A blood sample of 2 times 2 to 5 ml additional maximum
|
A blood sample of 2 times 2 to 5 ml additional maximum
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Complete sustainable remission (yes/no) for children with autoimmune haemolytic anemias
時間枠: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
|
At the screening
|
complete remission (yes/no) for children with autoimmune haemolytic anemias
時間枠: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
|
At the screening
|
partial remission (yes/no) for children with autoimmune haemolytic anemias
時間枠: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
|
At the screening
|
no response (yes/no) for children with autoimmune haemolytic anemias
時間枠:At the screening
|
Clinical Signs of Severe Anemia (Grade 3 or More) Or Hemoglobin <7 g / dl
|
At the screening
|
deceased patient (yes/no) for children with autoimmune haemolytic anemias
時間枠:At the screening
|
Death yes/no
|
At the screening
|
Complete sustainable remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
時間枠: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
|
At the screening
|
complete remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
時間枠: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
|
At the screening
|
partial remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
時間枠:At the screening
|
Clinical Signs of Hemorrhage (Grade 1 or 2) Or platelets between 30,000 and 100,000 / mm3
|
At the screening
|
no response (yes/no) for children with chronic immunologic thrombocytopenic purpura
時間枠:At the screening
|
Clinical Signs of Severe Hemorrhage (Grade 3 or Greater) Or Platelets <30,000 / mm3
|
At the screening
|
deceased patient (yes/no) for children with chronic immunologic thrombocytopenic purpura
時間枠:At the screening
|
Death yes/no
|
At the screening
|
協力者と研究者
捜査官
- 主任研究者:Yves PEREL, Pr、Bordeaux University Hsopital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Blood sampleの臨床試験
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University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
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Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
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Applied Science & Performance Institute完了
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Bedford Hospital NHS TrustAnglia Ruskin Universityわからない