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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name