UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of microbiota in tissue samples obtained by endoscopic ultrasonography-guided fine needle biopsy
Acronym	Analysis of microbiota in tissue samples obtained by endoscopic ultrasonography-guided fine needle biopsy
Scientific Title	Analysis of microbiota in tissue samples obtained by endoscopic ultrasonography-guided fine needle biopsy
Scientific Title:Acronym	Analysis of microbiota in tissue samples obtained by endoscopic ultrasonography-guided fine needle biopsy
Region	Japan

Condition
Condition	Hepatobiliary and Pancreatic Diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the microbiota within the tumor tissue and the relationship to samples that can be collected less invasively (saliva, feces, intestinal mucosa, digestive juices).
Basic objectives2	Others
Basic objectives -Others	To obtain findings that will lead to clinical applications, such as the development of new diagnostic treatments, the effective use of existing therapeutic agents, and the prediction of adverse events for drug therapies.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of tissue microbiota specific to various hepatobiliary and pancreatic diseases
Key secondary outcomes	Success rate of bacterial detection in tissues obtained by EUS-FNB Evaluation of the required sample volume, including area measurement, length, and cell count of EUS-FNB specimens for detection of microbiota by stereomicroscopic observation Association of bacteria flora with pancreatic duct and bile duct stenosis Identification of bacteria or bacterial genes associated with background pancreatic diseases (chronic pancreatic disease, pancreatic lipidosis, pancreatitis, etc.) diagnosed by CT/MRI or biopsy Relationships between other tissues (saliva, feces, intestinal mucosa, digestive juices) and microbiota and diversity in pancreatic tissues. Assessment of the relationship between progression and bacterial flora/diversity in malignant tumors Evaluation of the relationship between response to therapy and microbiota/diversity. Short-term/long-term prognosis and bacterial flora/diversity Assessment of the association between efficacy of drug therapy and adverse events and flora/diversity Bacterial flora analysis in cases with a final diagnosis of non-tumor lesions and its comparison with tumor lesions. Translated with www.DeepL.com/Translator (free version)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Scrape the mucosa of the gastrointestinal tract with a brush.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Among adults over 20 years of age undergoing endoscopic ultrasonography-guided fine needle biopsy (EUS-FNB) for mass lesions of the liver, biliary tract, or pancreas, those who understand the contents of this study and have given written consent to participate in the study are eligible.
Key exclusion criteria	Patients who wish to be excluded from the study If the principal investigator or sub-investigator determines that the patient is ineligible to participate in the study for any other reason.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kawashima Middle name Last name Hiroki
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	4668560
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
TEL	0527412111
Email	h-kawa@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Honda Middle name Last name Takashi
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	4668560
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
TEL	0527412111
Homepage URL
Email	honda@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
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	Ethics Committee
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
Tel	0527412111
Email	ytakada@med.nagoya-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	2022 Year 11 Month 17 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	Preinitiation
Date of protocol fixation	2022 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date	2022 Year 11 Month 17 Day
Last follow-up date	2026 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 17 Day
Last modified on	2022 Year 12 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056416