UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011546
Receipt No. 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

* 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 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
Email 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
Email hkitamura3539@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.