UMIN-CTR Clinical Trial

Basic information
Public title	A study on cancer screening in HIV-infected hemophiliacs
Acronym	Hemophilia cancer study
Scientific Title	A study on cancer screening in HIV-infected hemophiliacs
Scientific Title:Acronym	Hemophilia cancer study
Region	Japan

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

Objectives
Narrative objectives1	To explore incidence of NADM(Non AIDS-Defining Malignancies) in HIV-infected hemophiliacs
Basic objectives2	Others
Basic objectives -Others	Epidemiology
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To demonstrate incidence of NADM in HIV-infected hemophiliacs
Key secondary outcomes	To demonstrate background data of the patients and kinds of cancers diagnosed

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	Chest and abdominal CT scan including thyroid and prostate, gastric endoscopy, stool occult blood, and tumor markers of AFP, CEA, and PSA are performed twice with over one-year interval for the NADM screening.
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	(1)HIV-infected hemophiliacs who are attending an out-patient clinic of ACC (2)A written informed consent was obtained.
Key exclusion criteria	(1)Severe underlying and/or active AIDS diseases that need to be treated. (2)Patients who have difficulty to participate in this study due to psychological diseases. (3)Patients who are judged to be inappropriate in participation by the attending doctor.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-3202-7181
Email	oka@acc.ncgm.go.jp

Public contact
Name of contact person	1st name Shinichi Middle name Last name Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-3202-7181
Homepage URL
Email	oka@acc.ncgm.go.jp

Sponsor
Institute	AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Medical Research Management, Management and Planning Bureau, National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
Tel	+81-3-3202-7181
Email	rinrijm@hosp.ncgm.go.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	国立研究開発法人　国立国際医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 10 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	68
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	Completed
Date of protocol fixation	2019 Year 09 Month 17 Day
Date of IRB	2019 Year 09 Month 17 Day
Anticipated trial start date	2019 Year 11 Month 05 Day
Last follow-up date	2022 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	2019 Year 10 Month 08 Day
Last modified on	2022 Year 10 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043581