UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038231 |
|---|---|
| Receipt number | 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 | 2022/10/11 18:20:10 |
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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
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
oka@acc.ncgm.go.jp
Sponsor or person
Institute
AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
