UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Title of the study (Brief title)	Prospective study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Region	Japan

Condition
Condition	Early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The main objective is to examine the accuracy and efficacy of AICS for early gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positivity rate of AICS in early gastric cancer cases
Key secondary outcomes	Reduction rate of AICS value at 2 months and 1 year after resection of early gastric cancer in AICS positive cases

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) 20 to 90 years old male and female who can examine AICS and endoscopic examination. (2) Patients with early gastric cancer or suspicious of early gastric cancer that endoscopically resectable. (3) Patients who have consent for examination and treatment on their own will.
Key exclusion criteria	(1)Patients with Barrett adenocarcinoma, advanced gastric cancer and obvious other organ cancer. (2)Patients who are pregnant, may be pregnant, or prefer pregnancy during this study. (3)Patients judged unsuitable as subjects by doctor.
Target sample size	90

Research contact person
Name of lead principal investigator	Hiroaki Kaneko
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	3-9 Fukuura Kanazawa-ku Yokohama 236-0004, Japan
TEL	045-787-2326
Email	hero5722@yokohama-cu.ac.jp

Public contact
Name of contact person	Hiroaki Kaneko
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	3-9 Fukuura Kanazawa-ku Yokohama 236-0004, Japan
TEL	045-787-2326
Homepage URL
Email	hero5722@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Center for Novel and Exploratory Clinical Trials
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 08 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 30 Day
Anticipated trial start date	2018 Year 10 Month 01 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	This study is a cross-sectional study of patients with early gastric cancer who meet all inclusion criterias and visit our institution after October 2018. Before performing endoscopic treatment, we measure AICS value. For AICS positive cases, we use it as a main analysis target and analyze the effectiveness of AICS for early gastric cancer.

Management information
Registered date	2018 Year 08 Month 13 Day
Last modified on	2018 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038472