UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040834
Receipt number R000046618
Scientific Title Multicenter research on Vasal disease
Date of disclosure of the study information 2020/06/19
Last modified on 2020/12/19 09:35:45

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Basic information

Public title

Multicenter research on Vasal disease

Acronym

Tohoku Vasal disease Research

Scientific Title

Multicenter research on Vasal disease

Scientific Title:Acronym

Multicenter research on Vasal disease

Region

Japan


Condition

Condition

Vasal disease

Classification by specialty

Cardiology Surgery in general Vascular surgery
Radiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify short and long term outcomes of vasal disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate of Surgery / Treatment results of conservative management /Disease free survival rate / Overall survival rate / Recurrence rate of 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The present study includes all patients diagnosed and treated Vasal disease (arterial, venous and lymphatic disorder) .

Key exclusion criteria

The present study includes all patients diagnosed and treated Vasal disease (arterial, venous and lymphatic disorder) .

Target sample size

25000


Research contact person

Name of lead principal investigator

1st name Daijirou
Middle name
Last name Akamatsu

Organization

Tohoku University Hospital

Division name

Department of Surgery

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan

TEL

022-717-7214

Email

daijirou@surg.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Daijirou
Middle name
Last name Akamatsu

Organization

Tohoku University Hospital

Division name

Department of Surgery

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan

TEL

022-717-7214

Homepage URL


Email

daijirou@surg.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

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

Clinical Research, Innovation and Education Center, Tohoku University Hospital

Address

1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan

Tel

022-717-7122

Email

office@crieto.hosp.tohoku.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

2020 Year 06 Month 19 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

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 30 Day

Date of IRB

2020 Year 06 Month 26 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The present study includes patients diagnosed and treated vasal disease (arterial, venous and lymphatic disorder) in Tohoku university hospital and collaborating hospitals listed below.
<Collaborating institutes>
Sendai city hospital
JCHO Sendai hospital
JR Sendai hospital
Osaki citizen hospital
Japanese Red Cross Ishinomaki hospital
South Miyagi medical center
Kurihara central hospital
Kesen-numa City Hospital
Iwate prefectural Isawa hospital
Iwate prefectural Chubu hospital
Hachinohe city hospital


Management information

Registered date

2020 Year 06 Month 19 Day

Last modified on

2020 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046618


Research Plan
Registered date File name
2022/12/21 研究計画書.doc

Research case data specifications
Registered date File name
2022/12/21 データ仕様書.xlsx

Research case data
Registered date File name