UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035076 |
|---|---|
| Receipt number | R000039168 |
| Scientific Title | Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma? |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2021/11/01 15:22:24 |
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Basic information
Public title
Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Acronym
Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Scientific Title
Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Scientific Title:Acronym
Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Region
| Japan |
Condition
Condition
acromegaly
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Can pre-operative evaluation predict the post-operative prognosis and effectiveness of medication therapy in acromegaly?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploring pre-operative marker which can predict post-operative prognosis
Key secondary outcomes
1. relationship between diagnostic imaging study and hormonal findings
2. exploring effective factor of medication therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acromegaly based on `guideline of diagnosis and treatment with acromegaly` published by japan endocrine society.
Key exclusion criteria
nothing
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Sone |
Organization
Graduate school of medicine and faculty of medicine Kyoto university
Division name
Department of diabetes, endocrinology and nutrition
Zip code
6068501
Address
54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3560
kyotorinsho@gmail.com
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kawashima |
Organization
Kyoto university hospital
Division name
Department of diabetes, endocrinology and nutrition
Zip code
6068501
Address
54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3560
Homepage URL
kyotorinsho@gmail.com
Sponsor or person
Institute
Graduate school of medicine and faculty of medicine Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medicine and faculty of medicine Kyoto 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
Kyoto university graduate school and faculty of medicine, Kyoto university hospital Ethics committe
Address
54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2018 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
retrospective cross sectional study
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039168
