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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040630 |
Receipt No. | R000046373 |
Scientific Title | Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study. |
Date of disclosure of the study information | 2020/06/02 |
Last modified on | 2020/12/01 |
Basic information | ||
Public title | Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study. | |
Acronym | JCCG ALL-ASP19 | |
Scientific Title | Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study. | |
Scientific Title:Acronym | JCCG ALL-ASP19 | |
Region |
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Condition | ||
Condition | acute lymphoblastic leukemia (ALL) | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To identify silent inactivation of asparaginase by measuring serum asparaginase activity. |
Basic objectives2 | PK,PD |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The incidence of silent inactivation of asparaginase in patients with ALL. |
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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Newly diagnosed acute lymphoblastic leukemia
2) Registered to JPLSG CHM-14 study 3) Age below 40 years old 4) informed consent from patients or guardians |
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Key exclusion criteria | Judged to be inappropriate for registration by investigators | |||
Target sample size | 110 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Miyazaki Prefectual Miyazaki Hospital | ||||||
Division name | Division of Pediatrics | ||||||
Zip code | 880-8510 | ||||||
Address | 5-30,kitatakamatu, Miyazaki, Miyazaki 880-8510, JAPAN | ||||||
TEL | 0985-24-4181 | ||||||
shimono@med.miyazaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Miyazaki Prefectual Miyazaki Hospital | ||||||
Division name | Division of Pediatrics | ||||||
Zip code | 880-8510 | ||||||
Address | 5-30,kitatakamatu, Miyazaki, Miyazaki 880-8510, JAPAN | ||||||
TEL | 0985-24-4181 | ||||||
Homepage URL | |||||||
all-asp19@pref-hp.miyazaki.miyazaki.jp |
Sponsor | |
Institute | Japan Children's Cancer Study Group(JCCG) |
Institute | |
Department |
Funding Source | |
Organization | Gold Ribbon Network |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Miyazaki Prefectual Miyazaki Hospital |
Address | 5-30,kitatakamatu, Miyazaki, Miyazaki 880-8510, JAPAN |
Tel | 0985-24-4181 |
ikeno-takuya@pref.miyazaki.lg.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046373 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |