UMIN-CTR Clinical Trial

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
Email	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/
Email	iehara@koto.kpu-m.ac.jp

Sponsor
Institute	Japan Neuroblstoma Study Group
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022979