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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034248
Receipt No. R000039037
Scientific Title comprehensive analysis of duodenal adenoma/adenocarcinoma
Date of disclosure of the study information 2018/09/25
Last modified on 2019/06/28

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Basic information
Public title comprehensive analysis of duodenal adenoma/adenocarcinoma
Acronym comprehensive analysis of duodenal adenoma/adenocarcinoma
Scientific Title comprehensive analysis of duodenal adenoma/adenocarcinoma
Scientific Title:Acronym comprehensive analysis of duodenal adenoma/adenocarcinoma
Region
Japan

Condition
Condition duodenal adenoma/ adenocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 to clarify the genetic profile of deuodenal neoplasia
Basic objectives2 Others
Basic objectives -Others to clarify the genetic profile of deuodenal neoplasia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to clarify the genetic profile of duodenal neoplasia
Key secondary outcomes

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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients who have duodenal neoplasia
Key exclusion criteria those who do not consent with this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba university
Division name Department of gastroenterology
Zip code
Address 1-8-1 Cyuo ward Chiba city
TEL 09016283283
Email kenrunaway@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Arai
Organization Chiba university
Division name gastroenterology
Zip code
Address 1-8-1 Cyuo ward Chiba city
TEL 09016283283
Homepage URL
Email kenrunaway@yahoo.co.jp

Sponsor
Institute chiba university
Institute
Department

Funding Source
Organization self
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JPN

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 09 Month 25 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 06 Day
Date of IRB
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2018 Year 09 Month 24 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039037

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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