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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033733
Receipt No. R000038472
Scientific Title Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Date of disclosure of the study information 2018/08/13
Last modified on 2018/08/13

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Basic information
Public title Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Acronym Prospective study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Scientific Title Observational prospective single center study for the usefulness of AminoIndex cancer risk screening (AICS) in early gastric cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroaki Kaneko
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Hiroaki Kaneko
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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