Vulvar CancerVulvar-AINNCT03061435
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
A study testing Screening anal Pap smear - No high-resolution anoscopy and Screening anal Pap smear - High-resolution anoscopy in people with Vulvar Cancer and Cervical Cancer, run by Dr. Danielle Vicus at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia
- What is being tested?
- Screening anal Pap smear - No high-resolution anoscopy and Screening anal Pap smear - High-resolution anoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 1 Jan 2026
- Phase
- Interventional
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women age ≥ 40
- Previous diagnosis of VIN 2/3 or vulvar
Who cannot join
- Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer
- Women who are HIV positive
- Women currently taking immunosuppressant medication
- Women who have had a previous hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Dr. Danielle Vicus, MD
About this study
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.
- Conditions
- Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia
- Being tested
- Screening anal Pap smear - No high-resolution anoscopy, Screening anal Pap smear - High-resolution anoscopy
- Keywords
- Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV
- Medical subject headings
- Vulvar Neoplasms, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening anal Pap smear - No high-resolution anoscopyProcedure or surgery
75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy
Screening anal Pap smear - High-resolution anoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening anal Pap Smear - Negative (75%) | Other | All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention. Receives: Procedure: Screening anal Pap smear - No high-resolution anoscopy |
| Screening anal Pap Smear - Negative (25%) | Other | 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. Receives: Procedure: Screening anal Pap smear - High-resolution anoscopy |
| Screening anal Pap Smear - Positive | Other | 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. Receives: Procedure: Screening anal Pap smear - High-resolution anoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
Measured: 6 months to 1 year
Secondary outcomes (2)
Prevalence of AIN in women with VIN 2/3 or vulvar cancer
Measured: 6 months to 1 year
Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Feb 2021
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Danielle Vicus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Danielle Vicus, Sunnybrook Health Sciences Centre
- Investigators
- Danielle Vicus, MD, Principal investigator, Odette Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061435
- Sponsor's protocol ID
- GYNEOCC 3
- Acronym
- Vulvar-AIN
- Status last verified
- May 2025
- First submitted
- 17 Feb 2017
- Last updated
- 16 May 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
- ClinicalTrials.gov ID
- NCT03061435
- Acronym / sponsor ID
- Vulvar-AIN / GYNEOCC 3
- Conditions
- Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia
- Keywords
- Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dr. Danielle VicusUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Feb 2017 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening anal Pap Smear - Negative (75%) | Other | Procedure: Screening anal Pap smear - No high-resolution anoscopyAll patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention. |
| Screening anal Pap Smear - Negative (25%) | Other | Procedure: Screening anal Pap smear - High-resolution anoscopyAll 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. |
| Screening anal Pap Smear - Positive | Other | Procedure: Screening anal Pap smear - High-resolution anoscopyAll 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women age ≥ 40
- Previous diagnosis of VIN 2/3 or vulvar
Key exclusion criteria (4 listed)
- Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer
- Women who are HIV positive
- Women currently taking immunosuppressant medication
- Women who have had a previous hysterectomy
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 |
|---|---|---|
| Screening anal Pap smear - No high-resolution anoscopy75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy | Procedure or surgery | Screening anal Pap Smear - Negative (75%) |
| Screening anal Pap smear - High-resolution anoscopy25% 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. | Procedure or surgery | Screening anal Pap Smear - Negative (25%), Screening anal Pap Smear - Positive |
Primary outcome
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
Time frame: 6 months to 1 year
2 secondary outcomes
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
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 16 May 2025.
- Individual participant dataSharing planned: No
Related trials for Vulvar Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
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.
Danielle Vicus, MD principal investigator
Odette Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening anal Pap smear - No high-resolution anoscopy and Screening anal Pap smear - High-resolution anoscopy in people with Vulvar Cancer and Cervical Cancer, run by Dr. Danielle Vicus at 1 site in Canada.
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 2 inclusion and 4 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 16 May 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 Canada. 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 Nithla Mohanathas, BSc (4164805000 ext. 85838, nithla.mohanathas@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer (time frame: 6 months to 1 year). 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 16 May 2025.