UMIN-CTR Clinical Trial

Basic information
Public title	A comprehensive gene profile investigation of the patients with high risk etiology of colorectal cancer
Acronym	A comprehensive gene profile investigation of the patients with colorectal cancer
Scientific Title	A comprehensive gene profile investigation of the patients with high risk etiology of colorectal cancer
Scientific Title:Acronym	A comprehensive gene profile investigation of the patients with colorectal cancer
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	to clarify the gene mutation profile of colorectal cancer.
Basic objectives2	Others
Basic objectives -Others	to crarify the comprihensive profile of cororectal cancer with NGS.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Somatic and germline mutation of cororeactal cancer.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Gene
Interventions/Control_1	We perform fenetic analysis of tumor, non-tumor, plasma, buffy coat of patients of colorectal cancer.
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with colorectal cancer. patinents with previous treatment of colorectal cancer. patients with multiple colorectal cancer.
Key exclusion criteria	patients with FAP
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Arai
Organization	Chiba university
Division name	gastroenterology and neohrology
Zip code
Address	1-8-1 Cyuo ward Chiba city
TEL	043-222-7171
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Arai
Organization	Chiba university
Division name	gastroenterology and neohrology
Zip code
Address	043-222-7171
TEL	043-222-7171
Homepage URL
Email	araim-cib@umin.ac.jp

Sponsor
Institute	Chiba university
Institute
Department

Funding Source
Organization	self financing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 07 Month 29 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	2016 Year 04 Month 27 Day
Date of IRB	2016 Year 04 Month 27 Day
Anticipated trial start date	2016 Year 04 Month 27 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	Study is ongoing

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2020 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026952