UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035557 |
|---|---|
| Receipt number | R000040487 |
| Scientific Title | Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2020/04/03 09:14:43 |
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Basic information
Public title
Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Acronym
Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Scientific Title
Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Scientific Title:Acronym
Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Region
| Japan |
Condition
Condition
Adult growth hormone deficiency (AGHD)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, the GH releasing peptide (GHRP)-2 test is used to evaluate GH secretion. Although the cut-off levels of peak GH during GHRP-2 test for severe AGHD is 9 ng/ml, those values in patients with severe AGHD may vary from no-response to up to 9 ng/ml. We studied whether peak GH response during GHRP-2 test had an effect on difference in clinical characteristics in patients with NFPA.
Basic objectives2
Others
Basic objectives -Others
The patients with severe AGHD were divided into two groups depending on median of the preoperative GH peak values during the GHRP-2 test.We examined factors related to differences in two groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clarification of the difference between clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas.
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
76 patients who were underwent transsphenoidal surgery at Nippon Medical School Hospital between October 2012 and November 2017.
Key exclusion criteria
Patients who had a history of previous transsphenoidal surgery were excluded from the study.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sugihara |
Organization
Nippon Medical School Hospital
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
Address
1-1-5,Sendagi,Bunkyo-ku,Tokyo,113-8603,Japan
TEL
03-3822-2131
hitoshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi Fukuda |
Organization
Nippon Medical School Hospital
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
Address
1-1-5,Sendagi,Bunkyo-ku,Tokyo,113-8603,Japan
TEL
03-3822-2131
Homepage URL
i-fukuda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Hospital
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
Address
Tel
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 | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2019 | Year | 01 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040487
