UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	kubo.makoto.804@m.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055104