UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033188
Receipt No. R000037842
Official scientific title of the study Prospective exploratory study about prevalance of Helicobacter pylori infection for duodenal epithelial tumors
Date of disclosure of the study information 2018/07/05
Last modified on 2018/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Prospective exploratory study about prevalance of Helicobacter pylori infection for duodenal epithelial tumors
Title of the study (Brief title) PHD study
Region
Japan

Condition
Condition Duodenal epithelial tumors (DET) including tubular adenoma and intramucosal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the combined frequency of Helicobacter pylori (Hp) infection and other upper gastrointestinal tract disease for DET patients
Basic objectives2 Others
Basic objectives -Others To try to elucidate the pathophysiology of DETs, investigating for their mucous characteristics (gastric phenotype or intestinal phenotype)
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hp infectious state about mucous characteristics expressed for every DET patients
Key secondary outcomes (1) The presence of H.pylori irradication for DET patients
(2) The degree of endoscopic gastritis for DET patients
(3) The degree of microscopic intestinal metaplasia for DET patients
(4) The pathological findings of DET (location, tumor size, macroscopic findings, color, type of histopathology, mucous characteristics of the tumor)
(5) The frequency of Hp infection, the degree of endoscopic gastritis, and microscopic intestinal metaplasia at individual part of DET (oral side of papilla, papilla, and anal side of papilla)
(6) The frequency of Hp infection, the degree of endoscopic gastritis, and microscopic gastritis by the mucous characteristics of DET

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 DET patient over 20 year-old planned to be performed endoscopic resection (EMR, ESD or EP) by our team
Key exclusion criteria (1) known familiar adenomatous polyposis or hereditary non-polyposis colorectal cancer patient
(2) patient with past history for upper gastrointestinal tract operation
(3) patient with disorder about the function of blood coaglation, or impossibility for the adaptation according to the guideline for antithrombotic drugs of japanese gastroenterological endoscopy society
(4)patient with important organ dysfunction
(5)patient with another inappropreate reasons decided by the doctor
Target sample size 200

Research contact person
Name of lead principal investigator Motohiko Kato
Organization Keio University, school of medicine
Division name Gastroenterology
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 0333531211
Email motohikokato@keio.jp

Public contact
Name of contact person Atsushi Nakayama
Organization Keio University, school of medicine
Division name Cancer center, division of research and development for minimal invasive treatment
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 0333531211
Homepage URL
Email anakayama34@keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 07 Month 05 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 26 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information nothing

Management information
Registered date
2018 Year 06 Month 28 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.