UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030638
Receipt number R000034983
Scientific Title Screening survey and cohort construction of HTLV-1 in Ishigaki Island
Date of disclosure of the study information 2018/01/01
Last modified on 2019/01/08 11:52:32

* 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

Screening survey and cohort construction of HTLV-1 in Ishigaki Island

Acronym

Screening survey of HTLV-1 in Ishigaki Island

Scientific Title

Screening survey and cohort construction of HTLV-1 in Ishigaki Island

Scientific Title:Acronym

Screening survey of HTLV-1 in Ishigaki Island

Region

Japan


Condition

Condition

Human T-cell Leukemia Virus Type I (HTLV-1) carrier

Classification by specialty

Hematology and clinical oncology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

clarification of prevalence rate of HTLV-1 in Ishigaki Island

Basic objectives2

Others

Basic objectives -Others

prevalence rate of anti-parasite antibodies and distribution of HTLV-1 genotype

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

prevalence rate of anti-HTLV-1 antibody

Key secondary outcomes

prevalence rate of anti-parasite antibodies and distribution pattern of HTLV-1


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

Healthy islanders attending medical check-ups and outpatients (i.e., patients with diabetes) at Kariyushi Hospital

Key exclusion criteria

Outpatients with serious diseases including malignancies

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuya Fukushima

Organization

University of the Ryukyus

Division name

School of Health Sciences, Faculty of Medicine

Zip code


Address

207 Uehara, Nichihara, Okinawa, Japan

TEL

+81-98-895-1276

Email

fukutaku@med.u-ryukyu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuya Fukushima

Organization

University of the Ryukyus

Division name

School of Health Sciences, Faculty of Medicine

Zip code


Address

207 Uehara, Nichihara, Okinawa, Japan

TEL

+81-98-895-3331

Homepage URL


Email

fukutaku@med.u-ryukyu.ac.jp


Sponsor or person

Institute

University of the Ryukyus

Institute

Department

Personal name



Funding Source

Organization

Okinawa Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

沖縄県


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2015 Year 01 Month 07 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 01 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We detected 84 HTLV-1 carriers.


Management information

Registered date

2017 Year 12 Month 29 Day

Last modified on

2019 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034983


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name