UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Carbohydrate antigen19-9 (CA19-9) levels in patients with autosomal dominant polycystic kidney disease (ADPKD)
Title of the study (Brief title)	CA19-9 levels in ADPKD
Region	Japan

Condition
Condition	autosomal dominant polycystic kidney disease
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the serum CA19-9 levels and these associations with clinical parameters in ADPKD patients
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The serum CA19-9 levels
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ADPKD
Key exclusion criteria	under 18 y.o. and more than 90 y.o.
Target sample size	200

Research contact person
Name of lead principal investigator	Hirotaka Fukasawa
Organization	Iwata City Hospital
Division name	Renal Division
Address	512-3 Ohkubo, Iwata, Shizuoka
TEL	0538-38-5000
Email	hfukasawaucsd@gmail.com

Public contact
Name of contact person	Hirotaka Fukasawa
Organization	Iwata City Hospital
Division name	Renal Division
Address	512-3 Ohkubo, Iwata, Shizuoka
TEL	0538-38-5000
Homepage URL
Email	hfukasawaucsd@gmail.com

Sponsor
Institute	Iwata City Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: Cohort study Subjects: Patients eligible for the selection criteria in our institution since 2014 Measurement: Serum CA19-9 levels

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025073