UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009534
Receipt number	R000011184
Scientific Title	Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia
Date of disclosure of the study information	2012/12/12
Last modified on	2018/06/18 09:32:21

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Basic information

Public title

Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia

Acronym

Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia

Scientific Title

Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia

Scientific Title:Acronym

Analysis of Basophi activation test for L-asparaginase allergy in pediatric acute lymphoblastic leulkemia

Region

Japan

Condition

pediatric acute lymphoblastic leukemia, lymphoblastic lymphoma

Classification by specialty

Pediatrics

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Examination of usefulness of basophil activation test for L-aspraginase allergy in pediatric ALL/LBL

Basic objectives2

Others

Basic objectives -Others

Examination of usefulness of basophil activation test for L-aspraginase allergy in pediatric ALL/LBL

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

To examine wheter basophil activation test is useful for L-aspraginase allergy in pediatric ALL/LBL

Key secondary outcomes

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

0 years-old <=

Age-upper limit

20 years-old >

Gender

Male and Female

Key inclusion criteria

ALL/LBL

Key exclusion criteria

None

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Naoki Shimojo

Organization

Department of pediatrics,chiba university hospital

Division name

Pediatrics

Zip code

Address

1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name Moeko Hino

Organization

Department of pediatrics,chiba university hospital

Division name

Pediatrics

Zip code

Address

1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan

TEL

Homepage URL

Email

Sponsor or person

Institute

Naoki Shimojo

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 12 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

https://www.tandfonline.com/doi/full/10.3109/10428194.2013.794944

Number of participants that the trial has enrolled

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.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 04 Month 01 Day

Date of IRB

Anticipated trial start date

2012 Year 12 Month 12 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

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.

Management information

Registered date

2012 Year 12 Month 12 Day

Last modified on

2018 Year 06 Month 18 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011184

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name