UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051073
Receipt number R000056798
Scientific Title A pathophysiological investigation by using registry data and biobank in patients with Cronkhite-Canada syndrome
Date of disclosure of the study information 2023/05/16
Last modified on 2023/05/16 16:37:38

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Basic information

Public title

A pathophysiological investigation by using registry data and biobank in patients with Cronkhite-Canada syndrome

Acronym

registry data and a pathophysiological investigation in patients with Cronkhite-Canada syndrome

Scientific Title

A pathophysiological investigation by using registry data and biobank in patients with Cronkhite-Canada syndrome

Scientific Title:Acronym

registry data and a pathophysiological investigation in patients with Cronkhite-Canada syndrome

Region

Japan


Condition

Condition

Cronkhite-Canada syndrome

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to investigate the cause of Cronkhite-Canada syndrome.

Basic objectives2

Others

Basic objectives -Others

ND

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ND

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who diagnosed as cronkheit canada syndrome

Key exclusion criteria

Age <20

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Hokari

Organization

National Defense Medical College

Division name

department of internal medicine

Zip code

3598513

Address

Namiki 3-2

TEL

0429951609

Email

ryota@ndmc.ac.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Hokari

Organization

National Defense Medical College

Division name

department of internal medicine

Zip code

359-8513

Address

Namiki 3-2 Tokorozawa

TEL

0429951609

Homepage URL


Email

ryota@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name

Ryota Hokari


Funding Source

Organization

National Defense Medical College

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Defense Medical College

Address

Namiki3-2

Tel

0429951609

Email

ryota@ndmc.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

G1404

Org. issuing International ID_1

Kyoto Univ.

Study ID_2

RADDAR-J 82

Org. issuing International ID_2

The Rare Disease Data Registry of Japan (RADDAR-J)

IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 05 Month 16 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

2023 Year 04 Month 03 Day

Date of IRB

2023 Year 04 Month 03 Day

Anticipated trial start date

2023 Year 05 Month 16 Day

Last follow-up date

2043 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

registry study


Management information

Registered date

2023 Year 05 Month 16 Day

Last modified on

2023 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name