UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032447 |
|---|---|
| Receipt number | R000036997 |
| Scientific Title | Histogram analysis of iodine concentration values for the predicting therapeutic efficacy of pancreatic cancer before systemic chemotherapy |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2024/06/03 10:38:13 |
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Basic information
Public title
Histogram analysis of iodine concentration values for the predicting therapeutic efficacy of pancreatic cancer before systemic chemotherapy
Acronym
Histogram analysis of pancreatic cancer
Scientific Title
Histogram analysis of iodine concentration values for the predicting therapeutic efficacy of pancreatic cancer before systemic chemotherapy
Scientific Title:Acronym
Histogram analysis of pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the histogram analysis of iodine concentration values for the predicting therapeutic efficacy of pancreatic cancer before systemic chemotherapy
Basic objectives2
Others
Basic objectives -Others
To establish a reference value
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prediction of therapeutic efficacy of pancreatic cancer based on the iodine concentration before systemic chemotherapy
Key secondary outcomes
Prediction of therapeutic efficacy of pancreatic cancer based on the resectability assessment
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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adult patients with untreated pancreatic cancer who underwent dual energy CT and performed systemic chemotherapy
2. With pathological diagnosis of pancreatic ductal carcinoma
Key exclusion criteria
1. Patients under age of 20 years old
2. Can not obtain a consensus
3. Rare pathological type
4. Others (When the physician call inadequate)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Goshima |
Organization
Gifu University Hospital
Division name
Department of Radiology Services
Zip code
5011194
Address
1-1 Yanagido, Gifu City
TEL
058-230-6437
goshima@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Noda |
Organization
Gifu University Hospital
Division name
Department of Radiology
Zip code
5011194
Address
1-1 Yanagido, Gifu City
TEL
058-230-6437
Homepage URL
noda.yoshifumi.g9@f.gifu-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Gifu University
Institute
Department
Personal name
Funding Source
Organization
General Electric Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Support Part, School of Medicine, Gifu University
Address
1-1 Yanagido, Gifu City
Tel
058-230-6059
rinri@t.gifu-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
| 2018 | Year | 05 | Month | 07 | 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
71
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It took more time than initially envisioned to enroll participants.
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 | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
N.A.
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036997
