Hematological malignancy
Conditions
Interventions
None listed
Sponsors
Japan Children's Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: /Initial ALL (B-others of IR*, HR**, remission induction failure, or T-ALL) Or recurrent ALL (regardless of the number of relapses) Or initial AML Or recurrent AML (regardless of the number of relapses) /Cases registered in JPLSG-CHM-14 /Cases in which each sample of gene-analyzable tumor and normal cell (including remission phase) is obtained Tumor: bone marrow fluid (specimen with tumor cell ratio of 20% or more) Normal cell (including remission phase): peripheral blood in remission, and oral mucosa /Provided written consent by themselves/the representatives. *IR: other than HR and NCI-HR Or PGR, NCI-SR, and M3 on day 15. However, IR rises to HR in case of non-remission at TP1 (day 33). **HR: with one or more of the following HR factors: CNS 3 on day 1; PPR on day 8; MLL-AF4-positive by day 15; PGR, NCR-HR at PGR, and MG of day 15; E2A-HLF gene abnormality by day 29; or hypodiploid (44 or less) by day 29.
Exclusion criteria
Exclusion criteria: /Cases judged inappropriate for this study by the principal investigator or sub-investigators /Cases scheduled to participate in other studies for treatment purposes (sponsor-initiated clinical trials, investigator-initiated clinical trials, interventional clinical trials)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of cases in which PAF was identified by introducing the clinical sequence. | — |
Secondary
| Measure | Time frame |
|---|---|
| /Proportion of identification of CIF /An average number of days to return analysis results to the attending doctor /Proportion of cases unable to analyze genome and the cause /Proportion of cases in which germline mutation to be returned was identified | — |
Countries
Japan
Contacts
Public ContactShinsuke Hirabayashi
St.Luke's International Hospital Department of Pediatrics
Outcome results
None listed