UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024741 |
|---|---|
| Receipt number | R000028461 |
| Scientific Title | The study regarding screening tests for HIV complications associated with aging in HIV infected patients. |
| Date of disclosure of the study information | 2016/11/10 |
| Last modified on | 2019/02/20 17:03:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Acronym
The study of HIV complications and PET
Scientific Title
The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Scientific Title:Acronym
The study of HIV complications and PET
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 and dementia associated with aging in HIV infected patients through performing FDG-PET/CT examinations and ancillary tests (e.g. upper gastrointestinal endoscopy, chest CT, tumor marker test, head MRI, neuropsychological test, etc.).
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 and/or dementia 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 November 2016 to end of March 2019, we will conduct two malignant tumor screening tests, including FDG-PET/ CT examination, chest CT examination, upper gastrointestinal endoscopy, blood tumor marker test, stool test, urine test and blood chemistry study with an interval of more than one year in between tests. As a screening test for dementia, we will conduct head MRI, neuropsychological test, and FDG-PET/CT examination (also serves as a malignant tumor screening test) once.
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
Key inclusion criteria
1) HIV infected patients with hemophilia who are 35 years old or older
2) A consent to participate 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 participate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
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
Address
Tel
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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
