UMIN-CTR Clinical Trial

Basic information
Public title	Trial of Onco-Panel for Geneprofiling to Estimate both Adverse events and Response by cancer treatment
Acronym	TOP-GEAR
Scientific Title	Trial of Onco-Panel for Geneprofiling to Estimate both Adverse events and Response by cancer treatment
Scientific Title:Acronym	TOP-GEAR
Region	Japan

Condition
Condition	Cancer patient who will receive chemotherapy
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Genprofiling to estimate both adverse events and response of chemotherapy in cancer patients
Basic objectives2	Others
Basic objectives -Others	Geneprofiling
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Analysis of somatic gene mutation, gene expression of tumor tissue
Key secondary outcomes	Polymorphism analysis of genes related to the pharmacodynamics and pharmacokinetics in non-tumor tissue

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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Cancer patient who will recieve chemotherapy 2) Age over 1 year 3) Samples meeting one of the followings: 3)-1Tumor tissue i) Surplus sample stored in the NCC biobank ii) Surplus sample of diagnostic biopsy iii) Surgical surplus tumor sample iv) Newly-taken tumor sample for this study 3)-2 Non-tumor tissue i) Surplus tissue and blood in the NCC biobank ii) Newly-taken blood (5-20mL) for this study iii) Newly-taken oral mucosa for this study iv) Newly-taken non-tumor gastrointestinal mucosa for this study 4) Written informed consent
Key exclusion criteria	1) Judged ineligible by the clinical investigators
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Yamamoto
Organization	National Cancer Center Hospital
Division name	Department of Experimental Therapeutics
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	nbryamam@ncc.go.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Kondo
Organization	National Cancer Center Hospital
Division name	Department of Experimental Therapeutics
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	shkondo@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Hospital Certified Review Board
Address	5-1-1 Tsukiji, Chuo-ku
Tel	03-3542-2511
Email	ncch-irb@ml.res.ncc.go.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	2013 Year 07 Month 09 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	2013 Year 06 Month 21 Day
Date of IRB	2013 Year 06 Month 21 Day
Anticipated trial start date	2013 Year 06 Month 27 Day
Last follow-up date	2023 Year 06 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2013 Year 07 Month 07 Day
Last modified on	2019 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013046