UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035922
Receipt number R000040906
Scientific Title Analytical study of carbohydrate structure change of urological disease
Date of disclosure of the study information 2019/02/18
Last modified on 2022/07/31 15:41:24

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Basic information

Public title

Analytical study of carbohydrate structure change of urological disease

Acronym

Analytical study of carbohydrate structure change of urological disease

Scientific Title

Analytical study of carbohydrate structure change of urological disease

Scientific Title:Acronym

Analytical study of carbohydrate structure change of urological disease

Region

Japan


Condition

Condition

urological disease

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the carbohydrate structure which is a risk factor of development and progress of urological disease

Basic objectives2

Others

Basic objectives -Others

To identify the characteristics of carbohydrate structure of specimens of urinary diseases (blood, urine)

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of carbohydrate structure which is a risk factor for onset and progress of urological disease

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

18 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Those who have urological disease understand the purpose of research and can agree

Key exclusion criteria

Person not grown up
Those who can not agree to research

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Sato

Organization

Tohoku Medical and Pharmaceutical University

Division name

Department of Urology

Zip code

9838536

Address

1-15-1 Fukumuro, MIyagino-ku, Sendai, Miyagi, JAPAN

TEL

0222591221

Email

ms.hifu@tohoku-mpu.ac.jp


Public contact

Name of contact person

1st name Go
Middle name
Last name Anan

Organization

Tohoku Medical and Pharmaceutical University

Division name

Department of Urology

Zip code

983-8536

Address

1-15-1 Fukumuro, MIyagino-ku, Sendai, Miyagi, JAPAN

TEL

0222591221

Homepage URL


Email

goanan@tohoku-mpu.ac.jp


Sponsor or person

Institute

Tohoku Medical and Pharmaceutical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku Medical and Pharmaceutical University

Address

1-15-1 Fukumuro, MIyagino-ku, Sendai, Miyagi, JAPAN

Tel

0222591221

Email

tikenn@hosp.tohoku-mpu.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

2019 Year 02 Month 18 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

300

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

2018 Year 03 Month 23 Day

Date of IRB

2018 Year 03 Month 23 Day

Anticipated trial start date

2018 Year 03 Month 23 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

It aims to retrieve the glycosylation structure which is a risk factor of the onset and progress of urological disease and to use it for prevention of diseases and determination of treatment plan


Management information

Registered date

2019 Year 02 Month 18 Day

Last modified on

2022 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040906


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name