UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of quality of life in patients with adrenocortical tumor
Title of the study (Brief title)	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	Nagai So
Organization	Hokkaido University Hospital
Division name	Department of Medicine II
Address	Kita-ku Kita 14-jo Nishi 5-chome, Sapporo-shi, Hokkaido, Japan
TEL	011-706-5916
Email

Public contact
Name of contact person	Nagai So
Organization	Hokkaido University Hospital
Division name	Department of Medicine II
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
Email	nagai-s@med.hokudai.ac.jp

Sponsor
Institute	Department of Medicine II, Hokkaido University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 17 Day
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

Related information
URL releasing protocol	http://www.huhp.hokudai.ac.jp/patient/clinical/clinical.html
Publication of results	Unpublished
URL releasing results
Results	No significant results.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006284