UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050009 |
|---|---|
| Receipt number | R000056963 |
| Scientific Title | Observational study for residual tumors in low-risk and intermediate-risk neuroblastomas |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2023/01/11 10:42:14 |
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Basic information
Public title
Observational study for residual tumors in low-risk and intermediate-risk neuroblastomas
Acronym
JN-LI-21
Scientific Title
Observational study for residual tumors in low-risk and intermediate-risk neuroblastomas
Scientific Title:Acronym
JN-LI-21
Region
| Japan |
Condition
Condition
Neuroblastoma
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This observational study aims to identify treatment strategies for residual tumor after completion of induction chemotherapy in patients with low- and intermediate-risk neuroblastoma whose tumors have not been completely surgically removed at the start of treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
24-month progression-free survival
Key secondary outcomes
Overall Survival
Surgical complication
complications resulting from the absence of surgical treatment(e.g., tumor compression symptoms)
For dumbbell tumors, concomitant symptoms at time point 2 of evaluation
Subgroup analysis for progression-free survival rate and overall survival rate (e.g., INRG risk classification, COG risk classification)
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
Patients with histologically diagnosed neuroblastoma by biopsy (including bone marrow sampling) of a primary or metastatic tumor and who meet the following risk categories. However, patients with localized disease who have had a total tumor resection prior to chemotherapy are not eligible.
Key exclusion criteria
1) Cases of multiple cancers
2) Pregnant women, women who may be pregnant, or women who are breast-feeding
3) Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study
4) Cases with other illnesses, severe complications or severe malformations for which are inappropriate to participate in the study
5) Patients with INRG stage MS younger than 18 months of age who are classified as intermediate risk by COG risk classification and subsequently determined to have an abnormal 11q
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Yagyu |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pediatrics
Zip code
602-8566
Address
465 Kajii-Cho, Kawaramachihirokoji, Kamugyo-ku, Kyoto
TEL
0752515571
shigeky@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Yagyu |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pediatrics
Zip code
602-8566
Address
465 Kajii-Cho, Kawaramachihirokoji, Kamugyo-ku, Kyoto
TEL
0752515571
Homepage URL
http://www.jnbsg.jp/
shigeky@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japan Children's Cancer Group
Institute
Department
Personal name
Shigeki Yagyu
Funding Source
Organization
The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Kyoto Prefectural University of Medicine
Address
465 Kajii-Cho, Kawaramachihirokoji, Kamugyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2023 | Year | 01 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056963
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| Registered date | File name |
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| Registered date | File name |
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