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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026708
Receipt No. R000029899
Scientific Title A prospective study of prevalence rate of synchronous colorectal and gastric neoplasms and utility of ABC method for the patients of colorectal neoplasms.
Date of disclosure of the study information 2017/03/27
Last modified on 2017/09/26

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Basic information
Public title A prospective study of prevalence rate of synchronous colorectal and gastric neoplasms and utility of ABC method for the patients of colorectal neoplasms.
Acronym A prospective study of prevalence rate of synchronous colorectal and gastric neoplasms.
Scientific Title A prospective study of prevalence rate of synchronous colorectal and gastric neoplasms and utility of ABC method for the patients of colorectal neoplasms.
Scientific Title:Acronym A prospective study of prevalence rate of synchronous colorectal and gastric neoplasms.
Region
Japan

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

Objectives
Narrative objectives1 Prospective study to investigate the rate of synchronous gastric neoplasms in patients with colorectal neoplasms.
To assess the efficacy of ABC method for patients with colorectal neoplasms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence rate of synchronous gastric cancer in the patients with colorectal neoplasms.
Key secondary outcomes Sensitivity and specificity of ABC method for the patients with colorectal neoplasms.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver Other
Interventions/Control_1 endoscopy:once
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 regardless of sex
Patients who can obtain written informed consent for the participation of this study
Key exclusion criteria pregnant woman
brest feeding woman
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehide Fukuchi
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan
TEL 0452615656
Email take3232@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takehide Fukuchi
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan
TEL 0452615656
Homepage URL
Email take3232@gmail.com

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 03 Month 27 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 26 Day
Last modified on
2017 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029899

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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