UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015518 |
|---|---|
| Receipt number | R000017290 |
| Scientific Title | Efficacy and safety of preoperative somatostatine analogue treatment in acromegaly |
| Date of disclosure of the study information | 2014/10/24 |
| Last modified on | 2023/05/01 20:21:41 |
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Basic information
Public title
Efficacy and safety of preoperative somatostatine analogue treatment in acromegaly
Acronym
Efficacy and safety of preoperative somatostatine analogue treatment in acromegaly
Scientific Title
Efficacy and safety of preoperative somatostatine analogue treatment in acromegaly
Scientific Title:Acronym
Efficacy and safety of preoperative somatostatine analogue treatment in acromegaly
Region
| Japan |
Condition
Condition
Acromegaly
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of preoperative somatostatine analogue treatment in acromegaly
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cure rate of postoperative IGF-1 level
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been diagnosed with acromegaly
2) Patients with surgical indications of pituitary tumor
3) Patients who informed consent document
Key exclusion criteria
1) Patients with severe infections, liver disease, kidney disease, etc.
2) Patient who cannot be performed the necessary examination for evaluation.
3) Patients who investigator deem inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyoshi |
Organization
Hokkaido University
Division name
Division of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
Kita 15-jo Nishi 7-chome Kita-ku, Sapporo 060-8638 Japan
TEL
011-716-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Yamamoto |
Organization
Hokkaido University
Division name
Division of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
Kita 15-jo Nishi 7-chome Kita-ku, Sapporo 060-8638 Japan
TEL
011-716-5915
Homepage URL
kohei2031@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8638 Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study with historical control
Management information
Registered date
| 2014 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017290
