UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015737 |
|---|---|
| Receipt number | R000018306 |
| Scientific Title | Relationship between FDG PET finding and oncologic gene mutation in hepatic/cholangic/pancreatic tumors |
| Date of disclosure of the study information | 2014/12/04 |
| Last modified on | 2021/11/26 12:40:13 |
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Basic information
Public title
Relationship between FDG PET finding and oncologic gene mutation in hepatic/cholangic/pancreatic tumors
Acronym
FDG PET and oncologic mutation in hepatic/cholangic/pancreatic tumors
Scientific Title
Relationship between FDG PET finding and oncologic gene mutation in hepatic/cholangic/pancreatic tumors
Scientific Title:Acronym
FDG PET and oncologic mutation in hepatic/cholangic/pancreatic tumors
Region
| Japan |
Condition
Condition
malignant tumor of liver, bile duct system and pancreas.
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To varidate the effect of cancer related gene and its mutation on FDG uptake measured on PET imaging.
Basic objectives2
Others
Basic objectives -Others
Evaluation of effectiveness of iamging and its improvement.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical diagnosis, finding of FDG PET imaging and measured uptake of FDG. Pathological parameters measured on cancer sample such as invasiveness. Expression glucose transporter, hexokinese and G-6-Pase on cancer tissue. Expression and mutation of cancer related genes such as p53 on cancer tissue.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who were performed resection of hepatic/chorangic and pancreatic cancer and also performed FDG PET imaging during July 2010 and Sept 2014.
Key exclusion criteria
1: Patient with FDG PET image quality which is too poor to interpret.
2: The cases which the cancer tissue is not available.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Atomic bomb disease institute, Nagasaki University
Division name
Department of Radioisotope medicine
Zip code
8528523
Address
12-4 Sakamoto 1-chome, Nagasaki
TEL
095-819-7101
tkudo123@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Atomic bomb disease institute, Nagasaki University
Division name
Department of Radioisotope medicine
Zip code
8528523
Address
12-4 Sakamoto 1-chome, Nagasaki
TEL
095-819-7101
Homepage URL
tkudo123@nagasaki-u.ac.jp
Sponsor or person
Institute
Atomic bomb disease institute, Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Atomic bomb disease institute, Nagasaki 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
Nagasaki University Hospital
Address
1-12-4 Sakamoto, Nagasaki
Tel
095-819-7726
rinshou7726@umin.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
| 2014 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
48
Results
Now, analysis not including genome information are on going. Correlation between FDG uptake and histological infromation regarding tumor invasion (except lymphatic invasion) were observed in pancreatic cancer.
Results date posted
| 2021 | Year | 05 | Month | 27 | Day |
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
| 2014 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is retrospective observation study.
In this study, we compare FDG uptake measured on FDG PET imaging preoperatively and cancer related gene expression and mutations. Also evaluate relationship between FDG uptake and glusoce metabolism related factor, factor which affect on radiation sensitivity.
Management information
Registered date
| 2014 | Year | 11 | Month | 21 | Day |
Last modified on
| 2021 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018306
