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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029624
Receipt No. R000033838
Scientific Title The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Date of disclosure of the study information 2017/12/01
Last modified on 2018/04/27

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Basic information
Public title The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Acronym HIV aging study
Scientific Title The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Scientific Title:Acronym HIV aging study
Region
Japan

Condition
Condition HIV infection
Classification by specialty
Infectious disease
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find out the possibility of early detection of malignant tumors associated with aging in HIV infected patients through performing FDG-PET/CT examinations and tumor marker test.
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Presence of undiagnosed malignant tumor in HIV positive patients with hemophilia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Starting from December 2017 to the end of December 2020, we will conduct at least one malignant tumor screening tests, including FDG-PET/CT and blood tumor marker test.
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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) HIV infected patients with hemophilia who are 35 years old or older or
2) HIV litigation plaintiffs resident in Tokai block
and
3) Consent to participant has been obtained in a written form.
Key exclusion criteria 1) If an attending physician decides the patient requires urgent treatment
2)A patient with poor control of diabetes (FBS>150mg/dL)
3) A patient with serious underlying disease, which may lead to liver/kidney dysfunction and/or metabolic disorder
4) A patient with mental illness or psychiatric symptoms determined to confront difficulty when participating in the study
5)A patient with history of hypersensitivity to FDG
6) Other patients, whose attending physician has determined inappropriate to participant
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Yokomaku
Organization National Hospital Organization Nagoya Medical Center
Division name Department of AIDS clinic
Zip code
Address 4-1-1 Sannnomaru, Naka-ku, Nagoya, Aichi, Japan
TEL 052-951-1111
Email yokomaku@nnh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Yokomaku
Organization National Hospital Organization Nagoya Medical Center
Division name Department of AIDS clinic
Zip code
Address 4-1-1 Sannnomaru, Naka-ku, Nagoya, Aichi, Japan
TEL 052-951-1111
Homepage URL
Email yokomaku@nnh.hosp.go.jp

Sponsor
Institute National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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 名古屋医療センター(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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 30 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 19 Day
Last modified on
2018 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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