UMIN-CTR Clinical Trial

Basic information
Public title	Japanese multicenter prospective study on the differences in clinicopatholoigical features of colorectal cancer according to reasons for detection
Acronym	C-DETECT STUDY
Scientific Title	Japanese multicenter prospective study on the differences in clinicopatholoigical features of colorectal cancer according to reasons for detection
Scientific Title:Acronym	C-DETECT STUDY
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the differences in clinicopatholoigical features of colorectal cancer according to reasons for detection.
Basic objectives2	Others
Basic objectives -Others	Assessment of clinicopathological features
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinicopathological features of colorectal cancer
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients aged 20 years or older who have their first colorectal cancer treated in participating institutions
Key exclusion criteria	1) History of previous treatment for colorectal cancer 2) History of different colorectal cancers 3) Existence of inflammatory bowel disease 4) Existence of colorectal polyposis 5) Member of a hereditary colorectal cancer family 6) Difficult to examine using questionnaire 7) No consent for this study 8) Being considered inappropriate for participation by a physician in charge
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Takahisa Middle name Last name Matsuda
Organization	National Cancer Center Hospital
Division name	Cancer Screening Center
Zip code	1040045
Address	5-1-1 Tsukiji Chuo-ku, Tokyo, Japan
TEL	03-3547-5201
Email	tamatsud@ncc.go.jp

Public contact
Name of contact person	1st name Masau Middle name Last name Sekiguchi
Organization	National Cancer Center Hospital
Division name	Cancer Screening Center
Zip code	1040045
Address	5-1-1 Tsukiji Chuo-ku, Tokyo, Japan
TEL	03-3547-5201
Homepage URL
Email	masekigu@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	the National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	the Ethics Committee for Clinical Research of the National Cancer Center Hospital in Tokyo, Japan
Address	5-1-1 Tsukiji Chuo-ku, Tokyo, Japan
Tel	03-3547-5201
Email	irst@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	国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、静岡県立静岡がんセンター（静岡県）、栃木県立がんセンター（栃木県）

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 11 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	2020 Year 08 Month 31 Day
Date of IRB	2020 Year 09 Month 07 Day
Anticipated trial start date	2020 Year 09 Month 15 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Two years for registration and three years for data analysis etc.

Management information
Registered date	2020 Year 09 Month 11 Day
Last modified on	2021 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047662