HPV InfectionPAPIMALENCT05911750
Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
An observational study of HPV Infection and Dysplasia Anus, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- HPV Infection, Dysplasia Anus, Oral Cavity Disease
- What is being tested?
- Anal pap smear and oral swab for cytology and HPV testing
- Type of treatment
- Pill or oral medicine
- How many people
- 384 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2023to 1 Jun 2026
- 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 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau
Who may be able to join
- Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
- Male
- Age from 18 to 79 years
Who cannot join
- Unclassified Inflammatory Bowel Disease
- Diarrhea (> 3 bowel movements/day) with rectal bleeding at enrollment
- Prior full proctectomy
- Inability to collect the biological samples
- Inability to complete the questionnaire
- Refusal to sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona
Antonio Giordano, PhD, inflamatoria@santpau.cat
Antonio Giordano, PhD
About this study
Official title: Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.
Read the detailed description
Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained.
According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.
- Conditions
- HPV Infection, Dysplasia Anus, Oral Cavity Disease
- Being tested
- Anal pap smear and oral swab for cytology and HPV testing
- Keywords
- HPV, oral swab, anal swab
- Medical subject headings
- Papillomavirus Infections, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal pap smear and oral swab for cytology and HPV testingDiagnostic test
Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
| Study group | Role | What they receive |
|---|---|---|
| Male IBD patients | Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis). Receives: Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence (number/percentage) of HPV infection in oral and anal samples
PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.
Measured: Up to 12 months
Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples
Cytology changes will be reported according to the Bethesda classification.
Measured: Up to 12 months
Secondary outcomes (1)
Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.
Risk factors such as demographics, sexual conduct, and factors related to Inflammatory Bowel Disease (IBD) and IBD therapy will be evaluated through patient history research and the use of a self-administered questionnaire
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start12 Feb 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Giordano, MD, Principal investigator, dr.antoniogiordano@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911750
- Sponsor's protocol ID
- IIBSP-VHP-2023-47
- Acronym
- PAPIMALE
- Status last verified
- Jun 2025
- First submitted
- 30 May 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be only shared upon request and with IEC approval.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05911750
- Acronym / sponsor ID
- PAPIMALE / IIBSP-VHP-2023-47
- Conditions
- HPV Infection, Dysplasia Anus, Oral Cavity Disease
- Keywords
- HPV, oral swab, anal swab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Jun 2023 (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 study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.
Detailed description
Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained.
According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male IBD patients | – | Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testingMale patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau
Key inclusion criteria (3 listed)
- Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
- Male
- Age from 18 to 79 years
Key exclusion criteria (6 listed)
- Unclassified Inflammatory Bowel Disease
- Diarrhea (> 3 bowel movements/day) with rectal bleeding at enrollment
- Prior full proctectomy
- Inability to collect the biological samples
- Inability to complete the questionnaire
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 |
|---|---|---|
| Anal pap smear and oral swab for cytology and HPV testingAnal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology | Diagnostic test | Male IBD patients |
Primary outcome
Prevalence (number/percentage) of HPV infection in oral and anal samples
Time frame: Up to 12 months
PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.
Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples
Time frame: Up to 12 months
Cytology changes will be reported according to the Bethesda classification.
1 secondary outcome
Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.
Time frame: Up to 12 months
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 12 Sep 2025.
- Individual participant dataSharing planned: No. IPD will be only shared upon request and with IEC approval.
Related trials for HPV Infection
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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.
Antonio Giordano, MD principal investigator
dr.antoniogiordano@gmail.com
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 HPV Infection and Dysplasia Anus, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 6 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 12 Sep 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 Spain. 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 Antonio Giordano, MD (0034 932919000, dr.antoniogiordano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (number/percentage) of HPV infection in oral and anal samples (time frame: Up to 12 months). The study lists 2 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 12 Sep 2025.