UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033188
Receipt number R000037842
Scientific Title 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 2024/01/05 19:26:13

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Basic information

Public title

Prospective exploratory study about prevalance of Helicobacter pylori infection for duodenal epithelial tumors

Acronym

PHD study

Scientific Title

Prospective exploratory study about prevalance of Helicobacter pylori infection for duodenal epithelial tumors

Scientific Title:Acronym

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

500


Research contact person

Name of lead principal investigator

1st name Motohiko
Middle name
Last name Kato

Organization

Keio University, school of medicine

Division name

Center for Diagnostic and Therapeutic Endoscopy

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Email

motohikokato@keio.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Nakayama

Organization

Keio University, school of medicine

Division name

Cancer center, division of research and development for minimal invasive treatment

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Homepage URL


Email

anakayama34@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Ethics committee, Keio University, school of medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

0333531211

Email

med-rinri-jimu@adst.keio.ac.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

2018 Year 07 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

500

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

No longer recruiting

Date of protocol fixation

2018 Year 06 Month 26 Day

Date of IRB

2018 Year 06 Month 26 Day

Anticipated trial start date

2018 Year 08 Month 06 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2018 Year 06 Month 28 Day

Last modified on

2024 Year 01 Month 05 Day



Link to view the page

Value
https://center6.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