UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034497 |
|---|---|
| Receipt number | R000039329 |
| Scientific Title | Diagnostic value of EUS elastography and shear wave elastography for pancreatic solid masses |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2019/05/22 17:23:54 |
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Basic information
Public title
Diagnostic value of EUS elastography and shear wave elastography for pancreatic solid masses
Acronym
Usefulness of EUS elastography and shear wave elastography for pancreatic diseases
Scientific Title
Diagnostic value of EUS elastography and shear wave elastography for pancreatic solid masses
Scientific Title:Acronym
Usefulness of EUS elastography and shear wave elastography for pancreatic diseases
Region
| Japan |
Condition
Condition
pancreatic solid masse
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diagnostic performance of EUS elastography and shear wave elastography for pancreatic cancer and Comparison of the measurements of non-tumor lesion in each elastography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of EUS elastography and shear wave elastography for pancreatic cancer confirmed by pathological examination.
Key secondary outcomes
1
Relation between the measurements of each elastography and clinical features including pathological examination.
2.
Relation between the measurements of each elastography and radiological examinations including CT and MRI.
3.
Relation between the measurements of each elastography and effect of chemotherapy.
4. Comparison of the measurements of each elastography between non-tumor lesion of pancreatic cancer and control.
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
Patinets with pancreatic mass lesion and patients with non-pancreatic disease for control.
Patinets with written informed consent.
Key exclusion criteria
Patinets without written infromed consent.
Patinets considered ineligible for this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rintaro Mikata |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL
81-43-222-7171
mikata@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rintaro Mikata |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL
81-43-222-7171
Homepage URL
mikata@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
Address
Tel
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 | 10 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Nothing paticular
Management information
Registered date
| 2018 | Year | 10 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039329
