UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009570
Receipt number R000011231
Scientific Title Diagnostic sensitivity analysis of the immunochemical fecal occult blood test for colorectal cancers
Date of disclosure of the study information 2013/04/01
Last modified on 2019/06/27 09:39:45

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Basic information

Public title

Diagnostic sensitivity analysis of the immunochemical fecal occult blood test for colorectal cancers

Acronym

FIT STUDY

Scientific Title

Diagnostic sensitivity analysis of the immunochemical fecal occult blood test for colorectal cancers

Scientific Title:Acronym

FIT STUDY

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess diagnostic sensitivity of immunochemical fecal occult blood test for colorectal cancers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic sensitivity of immunochemical fecal occult blood test (FIT) for colorectal cancers based on the location, staging, tumor size and macroscopic types.

Key secondary outcomes

False positive and negative rates of immunochemical fecal occult blood test (FIT) for colorectal cancers based on the location, staging, tumor size and macroscopic types.


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

Other

Interventions/Control_1

Immunochemical fecal occult blood test (FIT) using OC sensor io (Eiken co)

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

Preoperative case over 20 years old who has a primary early/ advanced colorectal cancer.

Key exclusion criteria

Patient who has synchronous colorectal cancers, IBD and GI cancers.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Takahisa
Middle name
Last name Matsuda

Organization

National Cancer Center Hospital, Tokyo, Japan

Division name

Endoscopy Division

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email

tamatsud@ncc.go.jp


Public contact

Name of contact person

1st name Takahisa
Middle name
Last name Matsuda

Organization

National Cancer Center Hospital, Tokyo, Japan

Division name

Endoscopy Division

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

tamatsud@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital, Tokyo, Japan

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

tamatsud@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

National Cancer Center Hospital, Tokyo, Japan


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

636

Results

FIT had significantly lower sensitivity for proximal or early CRCs, even using two stool samples. The results of our findings on screening effectiveness need further study.

Results date posted

2019 Year 06 Month 27 Day

Results Delayed

Delay expected

Results Delay Reason

English paper's publication has not yet been completed

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

Completed

Date of protocol fixation

2014 Year 03 Month 27 Day

Date of IRB

2014 Year 07 Month 22 Day

Anticipated trial start date

2014 Year 07 Month 22 Day

Last follow-up date

2016 Year 05 Month 16 Day

Date of closure to data entry

2016 Year 05 Month 16 Day

Date trial data considered complete

2016 Year 05 Month 16 Day

Date analysis concluded

2016 Year 05 Month 18 Day


Other

Other related information



Management information

Registered date

2012 Year 12 Month 18 Day

Last modified on

2019 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011231


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name