UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025155 |
|---|---|
| Receipt number | R000028937 |
| Scientific Title | A prospective genetic study of patients with bilateral Wilms tumor for preparation of genetic counseling (RTBL14GP2) |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2019/12/10 16:10:26 |
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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
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/
haruta@cancer-c.pref.saitama.jp
Sponsor or person
Institute
Renal Tumor Committee, Japan Childrens Cancer Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028937
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