UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038763 |
|---|---|
| Receipt number | R000044193 |
| Scientific Title | A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2019/12/02 22:32:33 |
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Basic information
Public title
A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Acronym
A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Scientific Title
A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Scientific Title:Acronym
A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation with treatment for pancreatic cancer by using elastography in US or EUS for measuring the stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in pancreatic cancer stiffness
Key secondary outcomes
Characteristics
Clinical findings
Pathological findings
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 over 20 years old
2)Cases in which US or EUS was performed and the final diagnosis was pancreatic cancer
3)Written informed consent
Key exclusion criteria
1)minors
2)Not written informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of gastroenterology
Zip code
466-8560
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
ishitaku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakatsu |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of gastroenterology
Zip code
466-8560
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
Homepage URL
m-yoshi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
Nagoya University Graduate School of Medicine
Address
65 tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2602
m-yoshi@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
| 2019 | Year | 12 | Month | 05 | 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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2019 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044193
