UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011546 |
|---|---|
| Receipt number | R000013506 |
| Scientific Title | Research of early diagnosis and treatment with the examination of High Resolution Anoscopy (HRA) of anal canal squamous cell carcinoma caused by human papilloma virus (HPV) |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2019/08/29 22:21:10 |
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Basic information
Public title
Research of early diagnosis and treatment with the examination of High Resolution Anoscopy (HRA) of anal canal squamous cell carcinoma caused by human papilloma virus (HPV)
Acronym
Early diagnosis and treatment of HPV-related anal canal SCC with HRA
Scientific Title
Research of early diagnosis and treatment with the examination of High Resolution Anoscopy (HRA) of anal canal squamous cell carcinoma caused by human papilloma virus (HPV)
Scientific Title:Acronym
Early diagnosis and treatment of HPV-related anal canal SCC with HRA
Region
| Japan |
Condition
Condition
Human Papilloma Virus(HPV)-related anal canal squamous cell carcinoma
Classification by specialty
| Gastroenterology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Early detection and treatment of anal canal dysplasia~squamous cell carcinoma caused by human papilloma virus (HPV) with Japanese HIV-seropositive patients
Basic objectives2
Others
Basic objectives -Others
The risk of developing anal canal squamous cell carcinoma has been reported to be markedly elevated in HIV-positive patients (not onset of AIDS) with the local infection of human papilloma virus (HPV) in Europe and the United States.
For early detection of anal canal dysplasia, the cases of positiveness in the Anal Pap Smear (APS) as the screening examination are recommended with the observation and biopsy using High Resolution Anoscopy (HRA). But systematic examinating algorithm is not performed in Japan yet.
In this study, we verify the feasibility and the continuity of HRA as early diagnosis and treatment of dysplasia, identify the genotype of high-risk HPV, furthermore we research the relevance between the degree of dysplasia and CD4+ count/HIV-viral load of Japanese patients.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of dysplasia, carcinoma in situ of patients with APS-positiveness (Anal Intraepithelial Neoplasia [AIN] 1-3)
Key secondary outcomes
1. The sensitivity and specificity of APS about AIN grade using HRA
2. Identification of high-risk HPV genotype in Japan
3. Relevance between the incidence of dysplasia and CD4+ count, HIV-viral load using biopsy specimens harvested by HRA
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
Treatment
Type of intervention
| Gene | Device,equipment | Maneuver |
Interventions/Control_1
High Resolution Anoscopy (HRA) examination
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
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
HIV-seropositive patients (not onset of AIDS) revealed to be detected dysplasia by APS
Key exclusion criteria
Cases of advanced cancer at the time of initial examination and/or cases which cannot be inspected because of significant psychiatric and neurological disorders
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Furuse |
Organization
Kyorin University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
hkitamura3539@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitamura |
Organization
Kyorin University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
hkitamura3539@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Oncology, Kyorin University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shirakaba clinic
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
杏林大学病院（東京都）、立正佼成会附属佼成病院（東京都）、しらかば診療所（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
52 patients/above 50 pts totally expected
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
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013506
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