UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036842 |
|---|---|
| Receipt number | R000041973 |
| Scientific Title | Establishment of prediction method of malignancy and treatment resistance by fibrotic stroma quantification of pancreatic cancer using iodine map |
| Date of disclosure of the study information | 2019/05/25 |
| Last modified on | 2022/05/31 19:44:38 |
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Basic information
Public title
Establishment of prediction method of malignancy and treatment resistance by fibrotic stroma quantification of pancreatic cancer using iodine map
Acronym
Establishment of prediction method of malignancy and treatment resistance by fibrotic stroma quantification of pancreatic cancer using iodine map
Scientific Title
Establishment of prediction method of malignancy and treatment resistance by fibrotic stroma quantification of pancreatic cancer using iodine map
Scientific Title:Acronym
Establishment of prediction method of malignancy and treatment resistance by fibrotic stroma quantification of pancreatic cancer using iodine map
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the degree of fibrotic interstitium in pancreatic cancer using the iodine map obtained from Dual-Energy CT, and to predict the malignancy of pancreatic cancer and treatment-resistant pancreatic cancer
Basic objectives2
Others
Basic objectives -Others
The correlation between the parameter values obtained by contrast-enhanced MRI examination and PET examination performed before pancreatic cancer treatment and the degree of fibrotic interstitium in pancreatic cancer is evaluated, and the malignancy of pancreatic cancer and treatment-resistant pancreatic cancer in other examination images Assess whether prediction is possible.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Noninvasively predict malignancy and treatment resistance of pancreatic cancer by quantitatively measuring the degree of fibrotic interstitium in pancreatic cancer using an iodine map obtained from dynamic contrast-enhanced CT imaged by Dual-Energy CT .
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose medical information and prognosis information can be obtained from medical records.
Patients with a definite diagnosis of pancreatic cancer.
Patients undergoing treatment for pancreatic cancer at our hospital.
Key exclusion criteria
Patients who have not been requested to participate in this study from the published information.
Patients who are, or will be, participating in a clinical study with drug treatment interventions.
Patients who the research representative judged inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | atsuhiro |
| Middle name | |
| Last name | masuda |
Organization
kobe university
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | shigeto |
| Middle name | |
| Last name | ashina |
Organization
kobe university
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-6305
Homepage URL
sashina@med.kobe-u.ac.jp
Sponsor or person
Institute
kobe university
Institute
Department
Personal name
Funding Source
Organization
kobe university
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
kobe university
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
Tel
0783826669
kansatsu@med.kobe-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 | 05 | Month | 25 | 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
162
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
| 2019 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2019 | Year | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041973
