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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025230
Receipt No. R000029018
Scientific Title Analysis of human DNA metylation in patients with digestive organ cancer
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/12

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Basic information
Public title Analysis of human DNA metylation in patients with digestive organ cancer
Acronym DNA metylation of DOC
Scientific Title Analysis of human DNA metylation in patients with digestive organ cancer
Scientific Title:Acronym DNA metylation of DOC
Region
Japan

Condition
Condition Digestive organ diseases including digestive otrgan cancers
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the effficacy of human DNA metylation in patients with digestive organ diseases including digestive organ cancers and in healthy subject.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of DNA metylation on each digestive organ cancers
Key secondary outcomes 1. Comparison between DNA metylation and histological finding
2. DNA metylation and prognosis

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with digestive organ cancers
(1) Patients who are clinically diagnosed as digestive organ cancer (colorectal cancer, gastric cancer, pancreatic cancer, or liver cancer)
(2) Age >= 20 years; male and female
(3) Inpatient and outpatient
(4) Patients from whom informed consent is obtained
2. Patients with benign digestive organ diseases
(1) Patients who are diagnosed as benign digestive organ disease (colorectal adnoma, inflammatory bowel disease, gastric adenoma, gastric ulcer, chronic pancreatitis, or chronic liver disease)
(2) Age >= 20 years; male and female
(3) No objection to previous cancer with healed state
(4) Inpatient and outpatient
(5) Patients from whom informed consent is obtained
3. Healty subject
(1) Age >= 20 years; male and female
(2) NO digestive symptoms and no wight loss
(3) Parson who has a medical checkup result wihin 1 year
(4) Parson who has no abnormalities in a medical checkup result within 1 year
Key exclusion criteria 1. Patients with digestive organ cancers
(1) Patients with double cancer
(2) Patients who are judged as inadequacy due to other reasons
2. Patients with benign digestive organ diseases
(1) Patients who are judged as inadequacy due to other reasons
3. Healty subject
(1) Person with diabetes mellitus
(2) Person with previous cancer
(3) Person with previous colorectal disease
(4) Person with previous gastric disease
(5) Person with previous pancreatic disease
(6) Person with previous liver disease
(7) Person who is judged as inadequacy
Target sample size 1300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oncology and Laboratory Medicine
Zip code
Address 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2337
Email t.yama@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Idei
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oncology and Laboratory Medicine
Zip code
Address 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2337
Homepage URL
Email rinken@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

Funding Source
Organization None
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 01 Month 01 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
2016 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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 1. Detection rate of DNA metylation on each digestive organ cancer
2. Comparison between DNA metylation and histological finding
3. DNA metylation and prognosis

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029018

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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