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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039391
Receipt No. R000044778
Scientific Title Retrospective study for clinicopathological characteristics of superficial non-ampullary duodenal epithelial tumor
Date of disclosure of the study information 2020/05/01
Last modified on 2020/02/04

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Basic information
Public title Retrospective study for clinicopathological characteristics of superficial non-ampullary duodenal epithelial tumor
Acronym Clinicopathological characteristics of SNADET
Scientific Title Retrospective study for clinicopathological characteristics of superficial non-ampullary duodenal epithelial tumor
Scientific Title:Acronym Clinicopathological characteristics of SNADET
Region
Japan

Condition
Condition Adenoma and early carcinoma
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify clinical predictors of SNADET with malignant potential
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical findings correlated with the histological grade of category 4/5 in final histopathology
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with duodenal adenoma and carcinoma that undergone endoscopic or surgical resection
Key exclusion criteria 1)Lesions with gastric or extensive pancreatic involvement
2)Recurrent or residual lesion after endoscopic resection
3)Carcinomas invading the muscularis propria (T2) and deeper (T3 and T4)
4)Familial adenomatous polyposis
Target sample size 320

Research contact person
Name of lead principal investigator
1st name Noriya
Middle name
Last name Uedo
Organization Osaka International Cancer Institute
Division name Gastrointestinal Oncology
Zip code 541-8567
Address 3-1-69 Otemae, Chuo-ku, Osaka
TEL 06-6945-1181
Email uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Katsunori
Middle name
Last name Matsueda
Organization Osaka International Cancer Institute
Division name Gastrointestinal Oncology
Zip code 541-8567
Address 3-1-69 Otemae, Chuo-ku, Osaka
TEL 06-6945-1181
Homepage URL
Email rge43gs@yahoo.co.jp

Sponsor
Institute Osaka International Cancer Institute
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 Osaka International Cancer Institute institutional review board
Address 3-1-69 Otemae, Chuo-ku, Osaka
Tel 06-6945-1181
Email rinri01@opho.jp

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
2020 Year 05 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 328
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 Completed
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
2020 Year 01 Month 28 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2020 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrieving information from medical records or stored endoscopic images and we investigate the major outcomes in this retrospective study.

Management information
Registered date
2020 Year 02 Month 04 Day
Last modified on
2020 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044778

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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