UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041758
Receipt number R000047662
Scientific Title Japanese multicenter prospective study on the differences in clinicopatholoigical features of colorectal cancer according to reasons for detection
Date of disclosure of the study information 2020/09/11
Last modified on 2021/03/19 08:01:06

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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 or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047662


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name