UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049628 |
|---|---|
| Receipt number | R000056518 |
| Scientific Title | Survey on the occasion of diagnosis and prognosis of treatment of prolactinomas |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/02/01 14:15:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey on the occasion of diagnosis and prognosis of treatment of prolactinomas
Acronym
Survey on the occasion of diagnosis and prognosis of treatment of prolactinomas
Scientific Title
Survey on the occasion of diagnosis and prognosis of treatment of prolactinomas
Scientific Title:Acronym
Survey on the occasion of diagnosis and prognosis of treatment of prolactinomas
Region
| Japan |
Condition
Condition
prolactinoma
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a fact-finding study on the prognosis of treatment of patients with prolactinomas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prolactinoma Treatment Outcomes
Key secondary outcomes
1) Prognosis of treatment of prolactinomas in relation to blood test parameters
2) Prognosis of prolactinoma in relation to imaging parameters
3) Prognosis of treatment of prolactinomas in relation to the occasion of diagnosis
4) Prognosis of treatment of prolactinoma in relation to treatment details
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 prolactinomas aged 20 years or older
Key exclusion criteria
Subjects deemed inappropriate as research subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Department of Internal Medicine, Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
taisuke_uchida@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Uchida |
Organization
Department of Internal Medicine, Faculty of Internal Medicine, University
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
Homepage URL
taisuke_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Faculty of Internal Medicine, University
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Faculty of Internal Medicine, University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
Tel
0985-85-9403
rinken@med.miyazaki-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
| 2025 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate the actual situation regarding the prognosis of treatment in patients with prolactinomas. This study will be conducted as an academic research activity aimed at obtaining new knowledge in the field of endocrinology, metabolism, and diabetology.
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056518
