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NCT Number: NCT03061435

Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

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.

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Key information

Conditions

Vulvar Cancer Anal Cancer Anal Dysplasia Anus Diseases Anus Neoplasms Cervical Cancer Cervical Dysplasia Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV-Related Anal Squamous Cell Carcinoma Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vulvar Diseases Vulvar Dysplasia Vulvar Neoplasms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Dr. Danielle Vicus, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening anal Pap smear - No high-resolution anoscopy

Procedure

75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy

Screening anal Pap smear - High-resolution anoscopy

Procedure

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 outcomes

  1. Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer

    Time frame: 6 months to 1 year

Secondary outcomes

  1. Prevalence of AIN in women with VIN 2/3 or vulvar cancer

    Time frame: 6 months to 1 year

  2. Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN

    Time frame: 6 months to 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Anika Mohan, BSc

CONTACT

[email protected]

4164805000 ext. 89828

Nithla Mohanathas, BSc

CONTACT

[email protected]

4164805000 ext. 85838

Sponsors and collaborators

Lead sponsor

Dr. Danielle Vicus

Other

Registry information

Acronym: Vulvar-AIN

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2017
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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