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A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma caused by human papilloma virus (HPV)

A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma caused by human papilloma virus (HPV) - A study on High Resolution Anoscopy (HRA) for early detection of anal canal squamous cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043007
Enrollment
500
Registered
2021-01-15
Start date
2021-01-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal canal squamous cell carcinoma

Interventions

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 precan

Sponsors

National Center for Global Health and Medicine, Japan Institute for Health Security
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
HRA histological diagnosis will show the degree of anal intra-epitherial neoplasia (AIN) (grade 1-3) and prevalence of anal canal cancer

Secondary

MeasureTime frame
Rate of change in the degree of anal intra-epitherial neoplasia (AIN) (1 to 3) after histological diagnosis by HRA

Countries

Japan

Contacts

Public ContactNaokatsu Ando

National Center for Global Health and Medicine, Japan Institute for Health Security AIDS Clinical Center

ando.n@jihs.go.jp03-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026