UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005282 |
|---|---|
| Receipt number | R000006284 |
| Scientific Title | Prospective study of quality of life in patients with adrenocortical tumor |
| Date of disclosure of the study information | 2011/03/22 |
| Last modified on | 2018/09/27 10:12:31 |
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Basic information
Public title
Prospective study of quality of life in patients with adrenocortical tumor
Acronym
treatment of adrenocortical tumor and quality of life
Scientific Title
Prospective study of quality of life in patients with adrenocortical tumor
Scientific Title:Acronym
treatment of adrenocortical tumor and quality of life
Region
| Japan |
Condition
Condition
Adrenocortical tumor (including Cushing syndrome, Sub-clinical Cushing syndrome, Primary aldosteronism, non-functioning adrenal tumor)
Classification by specialty
| Endocrinology and Metabolism | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in quality of life before and after treatment in patients with adrenal tumor
Basic objectives2
Others
Basic objectives -Others
Changes in quality of life
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate changes in quality of life before and after treatment in patients with adrenocortical tumor
Key secondary outcomes
Comparison in quality of life between each diseases, treatments, complications. Relation between change in quality of life and endocrinological findings or clinical presentation.
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 who have newly diagnosed Cushing syndrome, Sub-clinical Cushing syndrome, Primary aldosteronism, non-functioning adrenal tumor and who voluntary write informed consent.
Key exclusion criteria
Patients who don't accept participation. Patients who have the disease that influence endocrine tests, such as infectious, hepatic, and renal diseases. Patients who are inappropriate for this study by research director.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagai So |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
Kita-ku Kita 14-jo Nishi 5-chome, Sapporo-shi, Hokkaido, Japan
TEL
011-706-5916
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagai So |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
Kita-ku Kita 14-jo Nishi 5-chome, Sapporo-shi, Hokkaido, Japan
TEL
011-706-5916
Homepage URL
http://www.huhp.hokudai.ac.jp/patient/clinical/clinical2011.html
nagai-s@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medicine II, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
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
北海道大学病院（北海道）
市立札幌病院（北海道）
NTT東日本札幌病院（北海道）
帯広厚生病院（北海道）
KKR札幌医療センター 斗南病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No significant 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
| 2010 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 01 | Day |
Other
Other related information
To evaluate changes in quality of life before and after treatment in patients with adrenocortical tumor, and comparison in quality of life between each diseases, treatments, complications. Relation between change in quality of life and endocrinological findings or clinical presentation.
Management information
Registered date
| 2011 | Year | 03 | Month | 21 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006284
