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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038231
Receipt No. R000043581
Scientific Title A study on cancer screening in HIV-infected hemophiliacs
Date of disclosure of the study information 2019/10/10
Last modified on 2019/11/05

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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
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 Enrolling by invitation
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
2019 Year 11 Month 05 Day


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

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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