UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049493 |
|---|---|
| Receipt number | R000056319 |
| Scientific Title | Comprehensive genetic analysis of endocrine tumors and surveillance of molecular targets for diagnosis and treatment. |
| Date of disclosure of the study information | 2022/11/14 |
| Last modified on | 2022/11/13 22:41:01 |
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Basic information
Public title
Comprehensive genetic analysis of endocrine tumors and surveillance of molecular targets for diagnosis and treatment.
Acronym
GAME(Genetic Analysis for Marianna Endocrine tumor) study
Scientific Title
Comprehensive genetic analysis of endocrine tumors and surveillance of molecular targets for diagnosis and treatment.
Scientific Title:Acronym
GAME(Genetic Analysis for Marianna Endocrine tumor) study
Region
| Japan |
Condition
Condition
Endocrine tumors with comorbidities and associated tumors.
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To search for genes and their mechanisms related to endocrine tumor development
Basic objectives2
Others
Basic objectives -Others
Perform genomic or exome sequencing to identify mutations occurring in tumor cells.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Discovery of novel gene mutations involved in endocrine tumor development
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those with a confirmed diagnosis of endocrine tumor, which is the target disease.
Key exclusion criteria
Patients without the informed consent of paper and who are judged to be unsuitable for this study.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Sone |
Organization
St. Marianna University School of Medicine
Division name
Endocrinology and Metabolism.
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
0449778111
h2tsukiyama@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakatsu |
| Middle name | |
| Last name | Sone |
Organization
St. Marianna University School of Medicine
Division name
Endocrinology and Metabolism.
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
0449778111
Homepage URL
h2tsukiyama@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University of Medicine hospital.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
0449778111
k-sienbu.mail@marianna-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
| 2022 | Year | 11 | Month | 14 | 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
| 2022 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056319
