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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023933
Receipt No. R000027481
Scientific Title To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Date of disclosure of the study information 2016/11/01
Last modified on 2018/04/09

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Basic information
Public title To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Acronym To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Scientific Title To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Scientific Title:Acronym To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Region
Japan

Condition
Condition brain tumor (glioma)
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the correlation between 11C-methionine (MET) PET uptake and signal transduction factors in patients with glioma.

We investigate the relationships between survival rate and MET uptake parameters, signal transduction factors, and clinicopathological factors. We elucidate the optimal prognostic markers of glioma among these relationships.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the optimal MET uptake parameter and signal transduction factor for prognosis of glioma patients.
Key secondary outcomes To reveal whether we predict the expression of signal transduction factors and the degree of malignancy using MET uptake parameters.

To investigate whether MET uptake and the expression of signal transduction factors have an influence on the management of therapy such as molecular target therapy in glioma patients.

To reveal the relationship between amino acid metabolism and tumorgenesis of glioma using MET uptake, signal transduction factors, and clnicopathological factors.

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
90 years-old >
Gender Male and Female
Key inclusion criteria (1)The patient undergoes MET PET/CT in Kindai University Hospital.
(2)The patient is diagnosed as glioma with CT, MRI and other clinical findings at neurosurgery in Kindai University Hospital, and is needed to surgery or biospsy.
(3)The age of the patient is over 20 age years.
(4)The document about the agreement with participation of this study is obtained from patient.
Key exclusion criteria (1)The patient has metastatic brain tumor, malignant lymphoma or other brain tumors and malignant tumors.
(2)The glioma patient without treatment adaptation.
(3)The document about the agreement with participation of this study is not obtained from patient.
(4)Pregnant woman, possibility of the pregnancy woman, lactating woman.
(5)The age of the patient is less than 20 age years.
(6)The patient cannot undergo PET/CT examination because of serious complication
(7)The doctor makes a judgement that the patient is not appropriate for participatingin this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hayato Kaida
Organization Kindai University Faculty of Medicine
Division name Department of Radiology
Zip code
Address Ohnohigashi 377-2, Osakasayama City, Osaka, 589-8511, Japan
TEL 072-366-0221
Email kaida@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayato Kaida
Organization Kindai University Faculty of Medicine
Division name Department of Radiology
Zip code
Address Ohnohigashi 377-2, Osakasayama City, Osaka, 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email kaida@med.kindai.ac.jp

Sponsor
Institute Department of Radiology, Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization Japan Society For the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kurume University School of Medicine.
Kurume University Hospital
Graduate School of Medicine/ Faculty of Medicine, Osaka University
Name of secondary funder(s) Kobe University Graduate School of Medicine

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 01 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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The purpose of this study is to show the correlation between MET uptake and signal trasduction factors, and reveal the optimal prognostic factors from the relationship between survival rate and MET uptake, signal trasduction factors and clinicopathological factors in glioma patients. In addition, we investigate pathological relationship between amino acid metabolism and tumor progression of glioma.

Management information
Registered date
2016 Year 09 Month 05 Day
Last modified on
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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