UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048347 |
|---|---|
| Receipt number | R000055104 |
| Scientific Title | Retrospective study regarding tumor mutational burden (TMB) based on the Center for Cancer Genomics and Advanced Therapeutic (C-CAT) database |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2022/07/12 11:06:44 |
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Basic information
Public title
Retrospective study regarding tumor mutational burden (TMB) based on the Center for Cancer Genomics and Advanced Therapeutic (C-CAT) database
Acronym
Retrospective study regarding tumor mutational burden (TMB) based on the Center for Cancer Genomics and Advanced Therapeutic (C-CAT) database
Scientific Title
Retrospective study regarding tumor mutational burden (TMB) based on the Center for Cancer Genomics and Advanced Therapeutic (C-CAT) database
Scientific Title:Acronym
Retrospective study regarding tumor mutational burden (TMB) based on the Center for Cancer Genomics and Advanced Therapeutic (C-CAT) database
Region
| Japan |
Condition
Condition
Solid tumors
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Pediatrics |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We investigate the characteristics of TMB in the Japanese population using the C-CAT database.
Basic objectives2
Others
Basic objectives -Others
We investigate the characteristics of TMB in the Japanese population using the C-CAT database.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of TMB in each solid tumor
Key secondary outcomes
1)Distribution of TMB by primary or metastatic tumor
2)Distribution of TMB by tumor sites
3)Distribution of TMB by age
4)Distribution of TMB by mutations
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
1)Patients undergoing cancer genome profiling test.
2) Patients having provided consent to get own data registered to C-CAT and for secondary use.
Key exclusion criteria
Patients having provided no consent to get own data registered to C-CAT and for secondary use.
Target sample size
11984
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City,812-8582,Japan
TEL
092-642-5440
kubo.makoto.804@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City,812-8582,Japan
TEL
092-642-5440
Homepage URL
kubo.makoto.804@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Cancer Genomics and Advanced Therapeutics: C-CAT
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Ethical Review Committe
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City,Japan
Tel
092-642-6254
ijkseimei@jimu.kyushu-u.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
| 2022 | Year | 07 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055104
