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 | 2025/02/05 18:50:53 |
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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
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
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
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
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We made a presentation at JDDW2024.
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037842
