UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019894 |
|---|---|
| Receipt number | R000022979 |
| Scientific Title | Observation study for neuroblastoma using cell-free DNA in serum |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2022/11/28 11:14:48 |
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Basic information
Public title
Observation study for neuroblastoma using cell-free DNA in serum
Acronym
Observation study for neuroblastoma using cell-free DNA in serum
Scientific Title
Observation study for neuroblastoma using cell-free DNA in serum
Scientific Title:Acronym
Observation study for neuroblastoma using cell-free DNA in serum
Region
| Japan |
Condition
Condition
neuroblastoma
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to observe the effectiveness of the observation infantile localized neuroblastoma without treatment prospectively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival period
Key secondary outcomes
therapeutic intervention period, ratio of the tumor progression cases
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
| 0 | days-old | <= |
Age-upper limit
| 547 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
1)day0-547days
2)Urinaly VMA and HVA level are high, the primary tumor shows positive of MIBG scintigraphy
3)L1 or L2 tumor
4) serum MYCN shows not amplification
Key exclusion criteria
1)Patients with life-threatening symptoms associated with tumor growth
2) Catecholamine secreting neuroblastoma patiets
3)physician determines patients unsuitable to participate in the study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Iehara |
Organization
Kyoto Prefectural University of Medicine
Division name
Pediatrics
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL
0752515111
iehara@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Iehara |
Organization
Kyoto Prefectural University of Medicine
Division name
Pediatrics
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL
0752515111
Homepage URL
http://www.jnbsg.jp/
iehara@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japan Neuroblstoma Study Group
Institute
Department
Personal name
Funding Source
Organization
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
Kyoto Prefectural University of Medicine
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
Tel
0752515111
iehara@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
| 2015 | Year | 12 | Month | 01 | 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
Date of protocol fixation
| 2015 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of the final cases registered after one year
Management information
Registered date
| 2015 | Year | 11 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022979
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
