UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of amino acid profile index for colorectal cancer screening.
Title of the study (Brief title)	A prospective study of amino index colorectal cancer screening
Region	Japan

Condition
Condition	early colorectal neoplasm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare performance of amino index cancer screening test with fecal immunochemical test for detection of early colorectal neoplasm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity of AICS for colorectal adenoma, intramucosal cancer and submucosal invasive 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	Historical
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	amino index cancer screening test and fecal immunochemical test
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who have 1)colorectal adenoma >= 20 mm 2)colorectal intramucosal cancer 3)colorectal submucosal invasive cancer
Key exclusion criteria	Patients 1) with inflammatory bowel disease 2) with familial adenomatous polyposis 3) have multiple primary neoplasms
Target sample size	300

Research contact person
Name of lead principal investigator	Takahisa Matsuda
Organization	National Cancer Center Hospital
Division name	Endoscopy division
Address	5-1-1,tsukiji,chuo-ku,Tokyo
TEL	03-3542-2511
Email	tamatsud@ncc.go.jp

Public contact
Name of contact person	Hiroyuki Takamaru
Organization	National Cancer Center Hospital
Division name	Endoscopy division
Address	5-1-1,tsukiji,chuo-ku,Tokyo
TEL	03-3542-2511
Homepage URL
Email	htakamar@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Institute for Inovation, Ajinomoto Co
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 05 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 15 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031327