UMIN-CTR Clinical Trial

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
Institute	Center Hospital of National Center for Global Health and Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034297