An interventional study of Screening anal Pap smear - No high-resolution anoscopy and Screening anal Pap smear - High-resolution anoscopy in Vulvar Cancer, Cervical Cancer and Vulvar Dysplasia, sponsored by Dr. Danielle Vicus. Recruiting at 1 site in Canada. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Dr. Danielle Vicus · Not applicable, Interventional, and Screening
Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.
Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.
236 studies on the registry are indexed under Vulvar Neoplasms; 69 are open to participants now.
This study's planned enrollment of 110 is above the median of 59 across 168 interventional studies indexed under Vulvar Neoplasms.
Browse Vulvar Neoplasms studies →This is the only study on the registry with Dr. Danielle Vicus as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.
Procedure: Screening anal Pap smear - No high-resolution anoscopy
All patients will receive an anal Pap test. Remaining 25% of patients will proceed to high-resolution anoscopy (HRA) clinic to assess the negative predictive rate of HRA.
Procedure: Screening anal Pap smear - High-resolution anoscopy
All patients will receive an anal Pap test. Any patient with abnormal cytology on their Pap test will be referred to HRA clinic for management. This includes potential biopsy and treatment.
Procedure: Screening anal Pap smear - High-resolution anoscopy
75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy
25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
Time frame: 6 months to 1 year
Prevalence of AIN in women with VIN 2/3 or vulvar cancer
Time frame: 6 months to 1 year
Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN
Time frame: 6 months to 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Aug 2025, 54 months after the start.
Of 43 non-industry interventional studies with no phase under Vulvar Neoplasms, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 129. This study's planned 54 months is above that.
Counting every sponsor, half of 43 studies reached it within 28 months; a quarter within 17 and three quarters within 129.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.