UMIN-CTR Clinical Trial

Basic information
Public title	A prospective genetic study of patients with bilateral Wilms tumor for preparation of genetic counseling (RTBL14GP2)
Acronym	A genetic study of bilateral Wilms tumor
Scientific Title	A prospective genetic study of patients with bilateral Wilms tumor for preparation of genetic counseling (RTBL14GP2)
Scientific Title:Acronym	A genetic study of bilateral Wilms tumor
Region	Japan

Condition
Condition	Bilateral Wilms tumor
Classification by specialty	Hematology and clinical oncology Surgery in general Pediatrics
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We will analyze genetic alterations in bilateral and familial Wilms tumors in order to accumulate data for genetic counseling.
Basic objectives2	Others
Basic objectives -Others	1) We analyze WT1 and other genes in tumors and blood of patients with bilateral Wilms tumor in order to identify causative germinal mutations. 2) We analyze the identified mutations in blood of parents and families in order to determine whether the mutation was inherited or developed de novo.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To identify various germinal mutations and the incidence of each germinal mutation, that caused bilateral Wilms tumor.
Key secondary outcomes	1) To clarify that the germinal mutations identified in patients with bilateral Wilms tumor are inherited from their parents or occurred de novo. 2) To identify germinal mutations in blood from families and to clarify the association between the mutation and their past history of Wilms tumor in order to determine the penetrance rates of bilateral Wilms tumor.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Registered patients to Multi-center clinical trial for Japanese children with bilateral nephroblastoma (RTBL14)
Key exclusion criteria	Patients not to register to Multi-center clinical trial for Japanese children with bilateral nephroblastoma (RTBL14)
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Yasuhiko Middle name Last name Kaneko
Organization	Research Institute for Clinical Oncology, Saitama Cancer Center
Division name	Cancer Diagnosis
Zip code	382-0806
Address	818 Komuro, Ina, Saitama, Japan
TEL	048-722-1111
Email	kanekowin@cancer-c.pref.saitama.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Haruta
Organization	Research Institute for Clinical Oncology, Saitama Cancer Center
Division name	Cancer Diagnosis
Zip code	362-0806
Address	818 Komuro, Ina, Saitama, Japan
TEL	048-722-1111
Homepage URL	http://jwits.umin.ac.jp/
Email	haruta@cancer-c.pref.saitama.jp

Sponsor
Institute	Renal Tumor Committee, Japan Childrens Cancer Group
Institute
Department

Funding Source
Organization	Japanese Agency of Medical Research and Development
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	The Ethics Committee of Saitama Cancer Center
Address	818 Komuro, Ina, Saitama, 362-0806, Japan
Tel	048-722-1111
Email	okuma.eiji@cancer-c.pref.saitama.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	埼玉県立がんセンター、臨床腫瘍研究所/Research Institute for Clinical Oncology, Saitama Cancer Center

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 06 Day

Related information
URL releasing protocol	http://jwits.umin.ac.jp/
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	Terminated
Date of protocol fixation	2014 Year 06 Month 05 Day
Date of IRB	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 05 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We have completed the genetic study of one patients and families, and continue the analysis of another case at present (December 6, 2016). The clinical study (RTBL14) was closed on March 31, 2019. The additional genetic study (RTBLGP2) was also closed on March 31, 2019 without publishing any reports.

Management information
Registered date	2016 Year 12 Month 06 Day
Last modified on	2019 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028937