UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043007 |
|---|---|
| Receipt number | R000048892 |
| Scientific Title | A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma caused by human papilloma virus (HPV) |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2024/07/23 10:32:23 |
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Basic information
Public title
A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma caused by human papilloma virus (HPV)
Acronym
A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma
Scientific Title
A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma caused by human papilloma virus (HPV)
Scientific Title:Acronym
A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma
Region
| Japan |
Condition
Condition
Anal canal squamous cell carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the prevalence and progression of anal canal dysplasia and squamous cell carcinoma in men who have sex with men (MSM).
Basic objectives2
Others
Basic objectives -Others
In the previous study, we conducted an annual anal cytology examination for MSM, and conducted an HPV cohort study for early detection of precancerous lesions and cancer caused by anal HPV infection. In this study, we will evaluate the presence or absence of early cancer, and the degree of progression of precancerous lesions (AIN1 to 3) by HRA in MSMs with abnormal findings on anal cytology. Patients with precancerous lesions should be followed up for HRA every 1-2 years. We will evaluate the prevalence and progression of anal and precancerous lesions.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HRA histological diagnosis will show the degree of anal intra-epitherial neoplasia (AIN) (grade 1-3) and prevalence of anal canal cancer
Key secondary outcomes
Rate of change in the degree of anal intra-epitherial neoplasia (AIN) (1 to 3) after histological diagnosis 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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
We will evaluate the presence or absence of early cancer, and the degree of progression of precancerous lesions (AIN1 to 3) by HRA in MSMs with abnormal findings on anal cytology. Patients with precancerous lesions should be followed up for HRA at least annually for 2 years.
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
Key inclusion criteria
1) Persons who have obtained written consent for participation in the research
2) MSM whose age at the time of obtaining consent is 20 years or older
3) Persons diagnosed with precancerous lesions as defined below by anal scraping cytology
Definition of precancerous lesions: Low grade squamous intraepithelial lesion (LSIL), atypical squamous cells, cannot exclude HSIL (ASC-H), high grade squamous intraepithelial lesion (HSIL), or atypical squamous cells of undetermined significance (ASC-US) with positive high-risk anal HPV
Key exclusion criteria
1) Those who are allergic to local anesthesia
2) Those who are judged by the principal researcher to be inappropriate for inclusion in the research
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Mizushima |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
dmizushi@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Naokatsu |
| Middle name | |
| Last name | Ando |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
nandou@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Reserch Management,Management and Planning Bureau National Center for Global Health and Medicine
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
Tel
03-3202-7181
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 15 | 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
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048892
