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 2021/01/20 09:35:57

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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 at least annually for 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

Changes in the degree of anal intra-epitherial neoplasia (AIN) (1 to 3) 1 year and 2 years 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

Email

dmizushi@acc.ncgm.go.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Shiojiri

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


Email

dshiojiri@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

Email

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

2025 Year 10 Month 31 Day

Date of closure to data entry

2025 Year 11 Month 30 Day

Date trial data considered complete

2025 Year 12 Month 31 Day

Date analysis concluded

2026 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 01 Month 15 Day

Last modified on

2021 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048892


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name