UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049543 |
|---|---|
| Receipt number | R000056416 |
| Scientific Title | Analysis of microbiota in tissue samples obtained by endoscopic ultrasonography-guided fine needle biopsy |
| Date of disclosure of the study information | 2022/11/17 |
| Last modified on | 2022/12/08 16:14:36 |
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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
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
honda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056416
