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用語の説明（詳細版）--準備中 |
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| 利用者名： | UMIN ID： |
| 試験進捗状況 | 試験終了/Completed |
| UMIN試験ID | UMIN000009534 |
| 受付番号 | R000011184 |
| 科学的試験名 | 小児急性リンパ性白血病患者におけるＬ－アスパラギナーゼに対する好塩基球活性化試験ＢＡＴの有用性の検討 |
| 一般公開日（本登録希望日） | 2012/12/12 |
| 最終更新日 | 2018/06/18 |
| 基本情報/Basic information | |||
| 一般向け試験名/Public title | 小児急性リンパ性白血病患者におけるＬ－アスパラギナーゼに対する好塩基球活性化試験ＢＡＴの有用性の検討 | Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia | |
| 一般向け試験名略称/Acronym | 小児急性リンパ性白血病患者におけるＬ－アスパラギナーゼに対する好塩基球活性化試験ＢＡＴの有用性の検討 | Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia | |
| 科学的試験名/Scientific Title | 小児急性リンパ性白血病患者におけるＬ－アスパラギナーゼに対する好塩基球活性化試験ＢＡＴの有用性の検討 | Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia | |
| 科学的試験名略称/Scientific Title:Acronym | 小児急性リンパ性白血病患者におけるＬ－アスパラギナーゼに対する好塩基球活性化試験ＢＡＴの有用性の検討 | Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia | |
| 試験実施地域/Region |
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| 対象疾患/Condition | |||
| 対象疾患名/Condition | 小児急性リンパ性白血病、リンパ芽球性悪性リンパ腫 | pediatric acute lymphoblastic leukemia, lymphoblastic lymphoma | |
| 疾患区分1/Classification by specialty |
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| 疾患区分2/Classification by malignancy | 悪性腫瘍/Malignancy | ||
| ゲノム情報の取扱い/Genomic information | いいえ/NO | ||
| 目的/Objectives | ||
| 目的1/Narrative objectives1 | 小児白血病、リンパ腫におけるL-asparaginaseアレルギーに対するBasohpil activaiton testの有用性の検討 | Examination of usefulness of basophil activation test for L-aspraginase allergy in pediatric ALL/LBL |
| 目的2/Basic objectives2 | その他/Others | |
| 目的2 -その他詳細/Basic objectives -Others | L-aspraginaseアレルギーと相関する因子の検討 | Examination of usefulness of basophil activation test for L-aspraginase allergy in pediatric ALL/LBL |
| 試験の性質1/Trial characteristics_1 | ||
| 試験の性質2/Trial characteristics_2 | ||
| 試験のフェーズ/Developmental phase | ||
| 評価/Assessment | ||
| 主要アウトカム評価項目/Primary outcomes | Basophil activation testがL-asparaginaseアレルギーを予測できるマーカーになるか評価する。 | To examine wheter basophil activation test is useful for L-aspraginase allergy in pediatric ALL/LBL |
| 副次アウトカム評価項目/Key secondary outcomes | ||
| 基本事項/Base | ||
| 試験の種類/Study type | 観察/Observational | |
| 試験デザイン/Study design | ||
| 基本デザイン/Basic design | ||
| ランダム化/Randomization | ||
| ランダム化の単位/Randomization unit | ||
| ブラインド化/Blinding | ||
| コントロール/Control | ||
| 層別化/Stratification | ||
| 動的割付/Dynamic allocation | ||
| 試験実施施設の考慮/Institution consideration | ||
| ブロック化/Blocking | ||
| 割付コードを知る方法/Concealment | ||
| 介入/Intervention | ||
| 群数/No. of arms | ||
| 介入の目的/Purpose of intervention | ||
| 介入の種類/Type of intervention | ||
| 介入1/Interventions/Control_1 | ||
| 介入2/Interventions/Control_2 | ||
| 介入3/Interventions/Control_3 | ||
| 介入4/Interventions/Control_4 | ||
| 介入5/Interventions/Control_5 | ||
| 介入6/Interventions/Control_6 | ||
| 介入7/Interventions/Control_7 | ||
| 介入8/Interventions/Control_8 | ||
| 介入9/Interventions/Control_9 | ||
| 介入10/Interventions/Control_10 | ||
| 適格性/Eligibility | |||||
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender | 男女両方/Male and Female | ||||
| 選択基準/Key inclusion criteria | 対象疾患に準じる | ALL/LBL | |||
| 除外基準/Key exclusion criteria | 同意がとれなかった者 | None | |||
| 目標参加者数/Target sample size | 50 | ||||
| 責任研究者/Research contact person | ||||||||||||||
| 責任研究者/Name of lead principal investigator |
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| 所属組織/Organization | 千葉大学大学院医学部付属病院 | Department of pediatrics,chiba university hospital | ||||||||||||
| 所属部署/Division name | 小児科 | Pediatrics | ||||||||||||
| 郵便番号/Zip code | ||||||||||||||
| 住所/Address | 千葉県千葉市中央区亥鼻１-８-１ | 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan | ||||||||||||
| 電話/TEL | ||||||||||||||
| Email/Email | ||||||||||||||
| 試験問い合わせ窓口/Public contact | ||||||||||||||
| 試験問い合わせ窓口担当者/Name of contact person |
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| 組織名/Organization | 千葉大学大学院医学部付属病院 | Department of pediatrics,chiba university hospital | ||||||||||||
| 部署名/Division name | 小児科 | Pediatrics | ||||||||||||
| 郵便番号/Zip code | ||||||||||||||
| 住所/Address | 千葉県千葉市中央区亥鼻１-８-１ | 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan | ||||||||||||
| 電話/TEL | ||||||||||||||
| 試験のホームページURL/Homepage URL | ||||||||||||||
| Email/Email | ||||||||||||||
| 実施責任組織/Sponsor | ||
| 機関名/Institute | その他 | Naoki Shimojo |
| 機関名/Institute （機関選択不可の場合） |
下条直樹 | |
| 部署名/Department | ||
| 研究費提供組織/Funding Source | ||
| 機関名/Organization | その他 | None |
| 機関名/Organization （機関選択不可の場合） |
なし | |
| 組織名/Division | ||
| 組織の区分/Category of Funding Organization | 自己調達/Self funding | |
| 研究費拠出国/Nationality of Funding Organization | ||
| その他の関連組織/Other related organizations | ||
| 共同実施組織/Co-sponsor | ||
| その他の研究費提供組織/Name of secondary funder(s) | ||
| IRB等連絡先（公開）/IRB Contact (For public release) | ||
| 組織名/Organization | ||
| 住所/Address | ||
| 電話/Tel | ||
| Email/Email | ||
| 他機関から発行された試験ID/Secondary IDs | ||
| 他機関から発行された試験ID/Secondary IDs | いいえ/NO | |
| 試験ID1/Study ID_1 | ||
| ID発行機関1/Org. issuing International ID_1 | ||
| 試験ID2/Study ID_2 | ||
| ID発行機関2/Org. issuing International ID_2 | ||
| 治験届/IND to MHLW | ||
| 試験実施施設/Institutions | ||
| 試験実施施設名称/Institutions | ||
| その他の管理情報/Other administrative information | ||||||||
| 一般公開日（本登録希望日）/Date of disclosure of the study information |
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| 関連情報/Related information | ||
| プロトコル掲載URL/URL releasing protocol | ||
| 試験結果の公開状況/Publication of results | 最終結果が公表されている/Published | |
| 結果/Result | ||
| 結果掲載URL/URL related to results and publications | https://www.tandfonline.com/doi/full/10.3109/10428194.2013.794944 | |
| 組み入れ参加者数/Number of participants that the trial has enrolled | ||
| 主な結果/Results | Leukemia and Lymphoma. 2014 Jan;55(1):92-6. doi: 10.3109/10428194.2013.794944. Epub 2013 May 15.
Expression of CD203c on basophils as a marker of immunoglobulin E-mediated (L)-asparaginase allergy. Hino M1, Shimojo N, Ochiai H, Inoue Y, Ando K, Chikaraishi K, Ota S, Okimoto Y, Sunami S, Nakamura R, Teshima R, Sato Y, Kohno Y. |
Leukemia and Lymphoma. 2014 Jan;55(1):92-6. doi: 10.3109/10428194.2013.794944. Epub 2013 May 15.
Expression of CD203c on basophils as a marker of immunoglobulin E-mediated (L)-asparaginase allergy. Hino M1, Shimojo N, Ochiai H, Inoue Y, Ando K, Chikaraishi K, Ota S, Okimoto Y, Sunami S, Nakamura R, Teshima R, Sato Y, Kohno Y. |
| 主な結果入力日/Results date posted | ||
| 結果掲載遅延/Results Delayed | ||
| 結果遅延理由/Results Delay Reason | ||
| 最初の試験結果の出版日/Date of the first journal publication of results | ||
| 参加者背景/Baseline Characteristics | ||
| 参加者の流れ/Participant flow | ||
| 有害事象/Adverse events | ||
| 評価項目/Outcome measures | ||
| 個別症例データ共有計画/Plan to share IPD | ||
| 個別症例データ共有計画の詳細/IPD sharing Plan description | ||
| 試験進捗状況/Progress | ||||||||
| 試験進捗状況/Recruitment status | 試験終了/Completed | |||||||
| プロトコル確定日/Date of protocol fixation |
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| 倫理委員会による承認日/Date of IRB | ||||||||
| 登録・組入れ開始（予定）日/Anticipated trial start date |
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| フォロー終了(予定)日/Last follow-up date | ||||||||
| 入力終了(予定)日/Date of closure to data entry | ||||||||
| データ固定（予定）日/Date trial data considered complete | ||||||||
| 解析終了(予定)日/Date analysis concluded | ||||||||
| その他/Other | ||
| その他関連情報/Other related information |
Author information Abstract Immediate allergy to l-asparaginase (ASP) is a major obstacle in treating lymphoid malignancies. ASP-specific immunoglobulin G (ASP-IgG) has been used as a surrogate marker. Recently, the CD203c-basophil activation test (BAT) was found to be useful in diagnosing IgE-mediated allergies. We compared the diagnostic utility of the CD203c-BAT to that of ASP-IgG levels in determining ASP allergies in children. Eight ASP allergic reactions occurred over 75 ASP treatment courses. The sensitivity, specificity and area under the receiver operating characteristic curve of CD203c-BAT were similar to the ASP-IgG levels (0.75 vs. 0.85, 0.82 vs. 0.78 and 0.81 vs. 0.85, respectively). Positive skin prick test results in patients with ASP allergy suggested that ASP-IgE was one of the key players in ASP allergy. A combination of the BAT with the ASP-IgG level had the highest specificity (0.95) and positive predictive value (0.62), which permitted us to identify ASP allergy more effectively. |
Author information Abstract Immediate allergy to l-asparaginase (ASP) is a major obstacle in treating lymphoid malignancies. ASP-specific immunoglobulin G (ASP-IgG) has been used as a surrogate marker. Recently, the CD203c-basophil activation test (BAT) was found to be useful in diagnosing IgE-mediated allergies. We compared the diagnostic utility of the CD203c-BAT to that of ASP-IgG levels in determining ASP allergies in children. Eight ASP allergic reactions occurred over 75 ASP treatment courses. The sensitivity, specificity and area under the receiver operating characteristic curve of CD203c-BAT were similar to the ASP-IgG levels (0.75 vs. 0.85, 0.82 vs. 0.78 and 0.81 vs. 0.85, respectively). Positive skin prick test results in patients with ASP allergy suggested that ASP-IgE was one of the key players in ASP allergy. A combination of the BAT with the ASP-IgG level had the highest specificity (0.95) and positive predictive value (0.62), which permitted us to identify ASP allergy more effectively. |
| 管理情報/Management information | ||||||||
| 登録日時/Registered date |
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| 最終更新日/Last modified on |
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| 閲覧ページへのリンク/Link to view the page | |
| URL(日本語) | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000011184 |
| URL(英語) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011184 |
| 研究計画書 | |
| 登録日時 | ファイル名 |
| 研究症例データ仕様書 | |
| 登録日時 | ファイル名 |
| 研究症例データ | |
| 登録日時 | ファイル名 |
