UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056899 |
|---|---|
| Receipt number | R000065033 |
| Scientific Title | A multicenter prospective observational study to assess the feasibility of biomarker testing in pediatric liver tumors. |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/01 19:08:24 |
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Basic information
Public title
A multicenter prospective observational study to assess the feasibility of biomarker testing in pediatric liver tumors.
Acronym
JPLT-5
Scientific Title
A multicenter prospective observational study to assess the feasibility of biomarker testing in pediatric liver tumors.
Scientific Title:Acronym
JPLT-5
Region
| Japan |
Condition
Condition
Pediatric liver tumor(hepatoblastoma, HCN-NOS, hepatocellular carcinoma)
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to ascertain the turnaround time for the results of molecular genetic analyses performed as a central test for pediatric liver tumors, and to assess the feasibility of risk-stratified treatment in practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days between submission of tumour specimens for molecular genetic analysis (biomarker analysis) and obtain of results of methylation analysis tested by ddPCR method (turnaround time; TAT).
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed or suspected primary childhood liver tumor (hepatoblastoma, HCN-NOS, hepatocellular carcinoma)
2. Age at diagnosis is less than 18 years
3. Written informed consent has been obtained from the patient or a surrogate
4. Informed consent has been obtained for central pathological review and genetic analysis in an observational study of pediatric solid tumors
5. Plasma (serum) samples can be collected before, during and after treatment
6. Clinical, imaging and pathological findings can be collected at diagnosis, during and after treatment
Key exclusion criteria
If the physicians at each facility determine that participation of patient in the study is not appropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Fujimura |
Organization
Juntendo university
Division name
Department of pediatricsf
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111ext3325
junya-f@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Fujimura |
Organization
Juntendo university
Division name
Department of pediatrics
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111ext3325
Homepage URL
junya-f@juntendo.ac.jp
Sponsor or person
Institute
pediatric liver tumor committee of Japan Children's Cancer Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Medical Research Ethics Committee
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
k.kawanishi.it@juntendo.ac.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
| 2025 | Year | 02 | Month | 10 | Day |
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
unremarkable
Management information
Registered date
| 2025 | Year | 02 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065033
