UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050715 |
|---|---|
| Receipt number | R000057781 |
| Scientific Title | A Retrospective Observational Study to Investigate the Prevalence of NTRK gene fusion positive in Solid Tumor in Japan |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/29 18:15:06 |
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Basic information
Public title
A Retrospective Observational Study to Investigate the Prevalence of NTRK gene fusion positive in Solid Tumor in Japan
Acronym
An observational study to learn more about NTRK gene fusion positive in Solid Tumor in Japan
Scientific Title
A Retrospective Observational Study to Investigate the Prevalence of NTRK gene fusion positive in Solid Tumor in Japan
Scientific Title:Acronym
An observational study to learn more about NTRK gene fusion positive in Solid Tumor in Japan
Region
| Japan |
Condition
Condition
Advanced solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of the study is to investigate the NTRK gene fusions prevalence, co-occurrence with relevant biomarkers/oncogenic drivers, associated fusion partners andcancer types/histology
Basic objectives2
Others
Basic objectives -Others
Prevalence of gene alteration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types.
Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric
Key secondary outcomes
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
Patients with any solid tumor and genome profiling results
Key exclusion criteria
None
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Taguchi |
Organization
Bayer Yakuhin, Ltd.
Division name
Medical Affairs & Pharmacovigilance
Zip code
100-0005
Address
Marunouchi 1-6-5, Chiyoda-ku, Tokyo, Japan
TEL
080-8525-4319
Tomoyuki.taguchi@bayer.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Taguchi |
Organization
Bayer Yakuhin, Ltd.
Division name
Medical Affairs & Pharmacovigilance
Zip code
100-0005
Address
Marunouchi 1-6-5, Chiyoda-ku, Tokyo, Japan
TEL
080-8525-4319
Homepage URL
Tomoyuki.taguchi@bayer.com
Sponsor or person
Institute
Bayer Yakuhin, Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS
Address
5-20-9 Mita, Minato City, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 04 | 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
46745
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
This study will extract the necessary information from the already registered data of subjects who have agreed to be registered with the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) in a secondary manner to evaluate the prevalence of NTRK fusion gene, fusion partner genes with the NTRK gene, and the correlation with other genetic alterations.
Data extraction will be performed by a person authorized to access the portal site designated by C-CAT from the principal investigator's organization, and the data set for analysis will be constructed by the principal investigator's organization. The constructed data set for analysis will be transferred to Syneos Health Clinical, a contractor with whom we have concluded an outsourcing agreement including confidentiality, for analysis. The transferred data set will be promptly destroyed after the completion of the study.
If, between the date of release of this information and June 30, 2023, the scheduled completion date of the study, a registered patient requests refusal of secondary use of the data, such data will not be included in the analysis. In that case, patients may refuse to allow their data to be used in this study by notifying C-CAT through their physician.
Management information
Registered date
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
