UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037109 |
|---|---|
| Receipt number | R000041682 |
| Scientific Title | Genetic analysis of multiple endocrine neoplasia type 1 |
| Date of disclosure of the study information | 2019/06/19 |
| Last modified on | 2019/06/19 13:19:28 |
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Basic information
Public title
Genetic analysis of multiple endocrine neoplasia type 1
Acronym
Genetic analysis of multiple endocrine neoplasia type 1
Scientific Title
Genetic analysis of multiple endocrine neoplasia type 1
Scientific Title:Acronym
Genetic analysis of multiple endocrine neoplasia type 1
Region
| Japan |
Condition
Condition
multiple endocrine neoplasia type 1
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Genetic analysis of multiple endocrine neoplasia type 1
Basic objectives2
Others
Basic objectives -Others
Genetic analysis of multiple endocrine neoplasia type 1
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic analysis of multiple endocrine neoplasia type 1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Being a patient (proband) with suspected or multiple endocrine neoplasia type 1 who is undergoing medical treatment at our hospital.
2) The person wants genetic analysis of multiple endocrine neoplasia type 1 (hereinafter, "the relevant genetic analysis"). However, if the subject is under 20 years of age or if it is not possible to make a decision by yourself, explain to the person under the presence of a representative and conduct genetic analysis after sufficiently respecting the person's intention. The signature on the consent form in this case shall be obtained from the representative. The agent is an optional guardian, a custodian, and the person who has a guardian. When there is not, we choose among people concerned from among spouse of adult donor, adult child, parents, adult brothers and sisters or grandchildren, grandparents, close relatives of those living or their close relatives Will be asked to
3) Having received as much explanation as possible from the person in charge of research or co-worker about the purpose, method and significance of the gene analysis, and the method of notifying the result of gene analysis, and agreeing on that.
Key exclusion criteria
Patients who do not get consent for this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Murao |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
Miki-cho, Kita-gun
TEL
+81878912230
labmed@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensaku |
| Middle name | |
| Last name | Fukunaga |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
Miki-cho, Kita-gun
TEL
+81878912230
Homepage URL
labmed@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa University Hospital
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
Kagawa University of Medicine Ethics Committee
Address
Miki-cho, Kita-gun
Tel
+81878912230
chiken@med.kagawa-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
| 2019 | Year | 06 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Genetic analysis of multiple endocrine neoplasia type 1
Management information
Registered date
| 2019 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
