UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007653 |
|---|---|
| Receipt number | R000008921 |
| Scientific Title | Clinical observation study of 5-year survivals in patients with newly diagnosed acute lymphoblastic leukemia (ALL) in Japan Adult Leukemia Study Group (JALSG). (JALSG-ALL-CS-12) |
| Date of disclosure of the study information | 2012/04/03 |
| Last modified on | 2020/03/14 18:56:32 |
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Basic information
Public title
Clinical observation study of 5-year survivals in patients with newly diagnosed acute lymphoblastic leukemia (ALL) in Japan Adult Leukemia Study Group (JALSG). (JALSG-ALL-CS-12)
Acronym
JALSG ALL clinical observation study 12 (JALSG-ALL-CS-12)
Scientific Title
Clinical observation study of 5-year survivals in patients with newly diagnosed acute lymphoblastic leukemia (ALL) in Japan Adult Leukemia Study Group (JALSG). (JALSG-ALL-CS-12)
Scientific Title:Acronym
JALSG ALL clinical observation study 12 (JALSG-ALL-CS-12)
Region
| Japan |
Condition
Condition
Acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
5-year survivals of acute lymphoblastic leukemia (ALL) and efficacy of stem cell transplantation therapy in the treatment of ALL, and accumulation of data for conducting JALSG ALL protocol.
Basic objectives2
Others
Basic objectives -Others
clinical observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) ALL patient 5-year survivals
(2) Effect of stem cell transplantation (SCT) on ALL patients
(3) Effect of timing of SCT and conditioning regimen on ALL patients
(4) Numbers of patients with ALL by age group, sex and type of diseases
(5) Feasibility of classification according to known prognostic factors
(6) Description of patients' status in chemotherapy program
(7) Remission duration due to chemotherapy
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Previously untreated ALL
Key exclusion criteria
Past history of chemotherapy or stem cell transplantation in the treatment of ALL
Target sample size
733
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hatta |
Organization
JALSG-ALL-CS-12 research secretariat
Division name
Hematology and Rheumatology, Nihon University School of Medicine
Zip code
173-8610
Address
30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
hatta.yosihiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hatta |
Organization
JALSG-ALL-CS-12 research secretariat
Division name
Hematology and Rheumatology, Nihon University School of Medicine
Zip code
173-8610
Address
30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
http://www.jalsg.jp
hatta.yosihiro@nihon-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Hokuyu hsopital IRB
Address
6-6-5-1 Higashi-Spporo, Shiroishi-ku, Sapporo
Tel
011-865-0111
iso.hokuyu@gmail.com
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
| 2012 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
http://www.jalsg.jp
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 01 | Day |
Other
Other related information
(1) ALL patient 5-year survivals
(2) Effect of stem sell transplantation (SCT) on ALL patients
(3) Effect of timing of SCT and conditioning regimen on ALL patients
(4) Numbers of patients with ALL by age group, sex and type of diseases
(5) Feasibility of classification according to known prognostic factors
(6) Description of patients' status in chemotherapy program
(7) Remission duration due to chemotherapy
Management information
Registered date
| 2012 | Year | 04 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008921
