UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Title of the study (Brief title)	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	Yoshiyuki Yokomaku
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of AIDS clinic
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	Yoshiyuki Yokomaku
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of AIDS clinic
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033838