Human Papilloma VirusNCT06697964
High Resolution Anuscopy Study
An observational study of Human Papilloma Virus and Anal Squamous Cell Carcinoma, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papilloma Virus, Anal Squamous Cell Carcinoma
- What is being tested?
- HRA
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Aug 2024to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent or will undergo High Resolution Anoscopy in UZ Brussel after Informed Consent
Who may be able to join
- All patients who have undergone HRA and all future patients referred for HRA in UZ Brussel
- 18 years or older
- Understands and able to speak and write in French, Dutch or English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, 1090
Magali Surmont, +32 2 477 ext. 60 11, magali.surmont@uzbrussel.be
About this study
The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately.
High-risk groups are screened through anal swabs for anal cytology and detection of high risk human papillomavirus (HR HPV). HRA referral is recommended for individuals with abnormal cytology.
Read more
HRA represents the only method to identify precancerous lesions of the anal canal, with only few specialists knowledgeable about it.
At UZ Brussel, the investigators collected a wealth of data about HPV infection and its association with anal pathology. By establishing a comprehensive study, the investigators can delve into this data with specific research questions, conducting valuable research to provide answers to pressing clinical questions and contribute to advancements in medical understanding and treatment.
- Being tested
- HRA
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRAOther
High resolution anoscopy to help evaluate anal conditions such as precancerous lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the prevalence of precancerous lesions in men who have sex with men using PrEP or are HIV positive Men
Measured: Through study completion, on average 5 years
Exploration of associations between abnormal histology and patient characteristics
Measured: Through study completion, on average 5 years
comparison of the prevalence of precancerous lesions in different groups
Measured: Through study completion, on average 5 years
to delineate unique features associated with HSIL in each risk group by linking patterns or characteristics
such as verrucous aspects, coarse punctuation, mosaic patterns, flat morphology, and fragility
Measured: Through study completion, on average 5 years
Prevalence of anal cancer among the at-risk populations
Measured: Through study completion, on average 5 years
correlation between abnormal histology and abnormal cytology, as well as HPV infection in MSM using PrEP and MSM living with HIV
Measured: Through study completion, on average 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start8 Aug 2024
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697964
- Sponsor's protocol ID
- HRA Study
- Status last verified
- Feb 2025
- First submitted
- 19 Sep 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Anuscopy Study
- ClinicalTrials.gov ID
- NCT06697964
- Acronym / sponsor ID
- HRA Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately.
High-risk groups are screened through anal swabs for anal cytology and detection of high risk human papillomavirus (HR HPV). HRA referral is recommended for individuals with abnormal cytology.
HRA represents the only method to identify precancerous lesions of the anal canal, with only few specialists knowledgeable about it.
At UZ Brussel, the investigators collected a wealth of data about HPV infection and its association with anal pathology. By establishing a comprehensive study, the investigators can delve into this data with specific research questions, conducting valuable research to provide answers to pressing clinical questions and contribute to advancements in medical understanding and treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent or will undergo High Resolution Anoscopy in UZ Brussel after Informed Consent
Key inclusion criteria (3 listed)
- All patients who have undergone HRA and all future patients referred for HRA in UZ Brussel
- 18 years or older
- Understands and able to speak and write in French, Dutch or English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRAHigh resolution anoscopy to help evaluate anal conditions such as precancerous lesions | Other | – |
Primary outcome
comparison of the prevalence of precancerous lesions in men who have sex with men using PrEP or are HIV positive Men
Time frame: Through study completion, on average 5 years
Exploration of associations between abnormal histology and patient characteristics
Time frame: Through study completion, on average 5 years
comparison of the prevalence of precancerous lesions in different groups
Time frame: Through study completion, on average 5 years
to delineate unique features associated with HSIL in each risk group by linking patterns or characteristics
Time frame: Through study completion, on average 5 years
such as verrucous aspects, coarse punctuation, mosaic patterns, flat morphology, and fragility
Prevalence of anal cancer among the at-risk populations
Time frame: Through study completion, on average 5 years
correlation between abnormal histology and abnormal cytology, as well as HPV infection in MSM using PrEP and MSM living with HIV
Time frame: Through study completion, on average 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus and Anal Squamous Cell Carcinoma, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali Surmont (+32 2 477 ext. 60 11, magali.surmont@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of the prevalence of precancerous lesions in men who have sex with men using PrEP or are HIV positive Men (time frame: Through study completion, on average 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.