Recruiting

Observational Study

Sponsor:

Dr. Danielle Vicus

Code:

NCT03061435

Conditions

Vulvar Cancer

Cervical Cancer

Vulvar Dysplasia

Cervical Dysplasia

Anal Cancer

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

Interventions

Screening anal Pap smear - No high-resolution anoscopy

Screening anal Pap smear - High-resolution anoscopy

Study Details

Brief 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. 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

Study ID

NCT03061435

Start date

Feb 1, 2021

Status verified date

May, 2025

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: 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.

other: 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.

other: 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.

Interventions

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 - 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.

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 ]

Central Contacts and Locations

Central contacts

Locations

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator:

Dr. Danielle Vicus, MD

More Information

Sponsor

Dr. Danielle Vicus

Last update posted

May 16, 2025

Last verified

May, 2025

Keywords

  • Vulvar Cancer
  • Cervical Cancer
  • Vulvar Dysplasia
  • Cervical Dysplasia
  • Anal Cancer
  • Anal Dysplasia
  • HPV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Danielle Vicus on 2025-05-16.