UMIN-CTR Clinical Trial

Basic information
Public title	The investigation of pathological mechanism and the identification of causal molecule in Anisakiasis -The indentification of species in Anisakiasis-
Acronym	The investigation of pathological mechanism and the identification of causal molecule in Anisakiasis -The indentification of species in Anisakiasis-
Scientific Title	The investigation of pathological mechanism and the identification of causal molecule in Anisakiasis -The indentification of species in Anisakiasis-
Scientific Title:Acronym	The investigation of pathological mechanism and the identification of causal molecule in Anisakiasis -The indentification of species in Anisakiasis-
Region	Japan

Condition
Condition	Anisakiasis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the patients' background and identification of species in anisakiasis, and we analyze the pathological mechanism in anisakiasis.
Basic objectives2	Others
Basic objectives -Others	Clinical features
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The investigation of the features of symptomatic anisakiasis and asymptomatic anisakiasis
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients who are older than 20 years old and less than 80 years old (2)patients who was picked out anisakis in esophagogastroduodenography.
Key exclusion criteria	Patients who are judged as being inappropriate for this study by their medical doctor
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Zip code	879-5593
Address	1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Japan
TEL	097-586-6193
Email	mizkaz0809@oita-u.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Zip code	879-5593
Address	1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Japan
TEL	097-586-6193
Homepage URL
Email	mizkaz0809@oita-u.ac.jp

Sponsor
Institute	Oita university
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Oita 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	General Clinical Research Center, Oita University Hospital
Address	1-1, idaigaoka, hasama, Yufu, Oita, Japan
Tel	097-586-6163
Email	gcrcjimu@oita-u.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	2016 Year 10 Month 10 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	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 20 Day
Date of IRB	2016 Year 05 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Under the investigation

Management information
Registered date	2016 Year 10 Month 10 Day
Last modified on	2021 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028036