UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044085 |
|---|---|
| Receipt number | R000050111 |
| Scientific Title | Prospective validation study for evaluation of tumor cell content rate in stereomicroscopic on-site evaluation of the EUS-guided tissue acquistion for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/05/01 19:44:59 |
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Basic information
Public title
Prospective validation study for evaluation of tumor cell content rate in stereomicroscopic on-site evaluation of the EUS-guided tissue acquistion for unresectable pancreatic cancer
Acronym
Prospective validation study for evaluation of tumor cell content rate in stereomicroscopic on-site evaluation of the EUS-guided tissue acquistion for unresectable pancreatic cancer
Scientific Title
Prospective validation study for evaluation of tumor cell content rate in stereomicroscopic on-site evaluation of the EUS-guided tissue acquistion for unresectable pancreatic cancer
Scientific Title:Acronym
Prospective validation study for evaluation of tumor cell content rate in stereomicroscopic on-site evaluation of the EUS-guided tissue acquistion for unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate adecuacy of tumor cell content rate in stereomicroscopic on-site evaluation of the EUS-guided tissue acquistion for unresectable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of histopathological specimens with tumor cell content rate greater than 20%.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
procedure of the EUS-TA with SOSE
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) Pancreatic cancer which are required EUS-TA for pathological diagnosis
2) Patients whom suspected unresectable pancreatic cancer
3) Adequate organ functions
4) Providing written informed consent, and age over 20
Key exclusion criteria
None
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa,Japan
TEL
+81-42-778-8111
kokuwaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa,Japan
TEL
+81-42-778-8111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Institutional Ethics Committee of Kitasato University Hospital
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
Tel
+81-42-778-7756
rinri@med.kitasato-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
| 2021 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
67
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
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050111
