UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030034
Receipt number R000034297
Scientific Title Genome Analysis on Lymph-related Diseases
Date of disclosure of the study information 2017/11/20
Last modified on 2021/05/27 09:03:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Genome Analysis on Lymph-related Diseases

Acronym

Genome Analysis on Lymph-related Diseases

Scientific Title

Genome Analysis on Lymph-related Diseases

Scientific Title:Acronym

Genome Analysis on Lymph-related Diseases

Region

Japan


Condition

Condition

Lymph-related diseases

Classification by specialty

Medicine in general Surgery in general Plastic surgery

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to promote a genome analysis on lymph-related diseases and to introduce its achievements into clinical situations.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of biomarkers which can reflect the targeted oetiology amongst the case and the control groups

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

blood taking

Interventions/Control_2

Surgery (only on the subjects who require operations in the patients group)

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 with lymph-related disease who are treated at Center Hospital of National Center for Global Medicine and Health
patients with written informed consent

Key exclusion criteria

Disorder of consciousness
Lacking of competency to consent
Severe anaemia (Hb < 8.0g/dL)
Considered not eligible for this study by the researchers

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Takumi
Middle name
Last name amamoto

Organization

Center Hospital of National Center for Global Health and Medicine

Division name

Plastic and Reconstructive Surgery

Zip code

162-8655

Address

1-21-1 Toyama Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

tyamamoto-tky@umin.ac.jp


Public contact

Name of contact person

1st name Takumi
Middle name
Last name Yamamoto

Organization

Center Hospital of National Center for Global Health and Medicine

Division name

Plastic and Reconstructive Surgery

Zip code

162-8655

Address

1-21-1 Toyama Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

tyamamoto-tky@umin.ac.jp


Sponsor or person

Institute

Center Hospital of National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

Self Funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Global Health and Medicine

Address

Toyama 1-21-1, Shinjuku-ku, Tokyo, Japan

Tel

0332027181

Email

tyamamoto-tky@umin.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

2017 Year 11 Month 20 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

Terminated

Date of protocol fixation

2017 Year 11 Month 20 Day

Date of IRB

2017 Year 11 Month 20 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 20 Day

Last modified on

2021 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name