Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. (Vulvar-AIN)
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ClinicalTrials.gov Identifier: NCT03061435 |
Recruitment Status :
Recruiting
First Posted : February 23, 2017
Last Update Posted : May 12, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Vulvar Cancer Cervical Cancer Vulvar Dysplasia Cervical Dysplasia Anal Cancer Anal Dysplasia HPV-Related Anal Squamous Cell Carcinoma | Procedure: Screening anal Pap smear - No high-resolution anoscopy Procedure: Screening anal Pap smear - High-resolution anoscopy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. |
Actual Study Start Date : | February 1, 2021 |
Estimated Primary Completion Date : | February 1, 2022 |
Estimated Study Completion Date : | February 1, 2023 |

Arm | Intervention/treatment |
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Screening anal Pap Smear - Negative (75%)
All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.
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Procedure: Screening anal Pap smear - No high-resolution anoscopy
75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy |
Screening anal Pap Smear - Negative (25%)
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.
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Procedure: Screening anal Pap smear - 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. |
Screening anal Pap Smear - Positive
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.
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Procedure: Screening anal Pap smear - 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 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women age ≥ 40
- Previous diagnosis of VIN 2/3 or vulvar
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061435
Contact: Nithla Mohanathas, BSc | 4164805000 ext 85838 | nithla.mohanathas@sunnybrook.ca | |
Contact: Anika Mohan, BSc | 4164805000 ext 89828 | anika.mohan@sunnybrook.ca |
Canada, Ontario | |
Odette Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Principal Investigator: Dr. Danielle Vicus, MD |
Principal Investigator: | Danielle Vicus, MD | Odette Cancer Centre |
Responsible Party: | Dr. Danielle Vicus, Dr. Danielle Vicus, MD, MSc, FRCSC, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT03061435 |
Other Study ID Numbers: |
GYNEOCC 3 |
First Posted: | February 23, 2017 Key Record Dates |
Last Update Posted: | May 12, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vulvar Cancer Cervical Cancer Vulvar Dysplasia Cervical Dysplasia |
Anal Cancer Anal Dysplasia HPV |
Uterine Cervical Neoplasms Anus Neoplasms Vulvar Neoplasms Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia Hyperplasia Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases |
Uterine Diseases Pathologic Processes Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Vulvar Diseases Precancerous Conditions Carcinoma in Situ |