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

Primary Purpose

Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Screening anal Pap smear - No high-resolution anoscopy
Screening anal Pap smear - High-resolution anoscopy
Sponsored by
Dr. Danielle Vicus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Vulvar Cancer focused on measuring Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Odette Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Screening anal Pap Smear - Negative (75%)

Screening anal Pap Smear - Negative (25%)

Screening anal Pap Smear - Positive

Arm Description

All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence of AIN in women with VIN 2/3 or vulvar cancer
Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN

Full Information

First Posted
February 17, 2017
Last Updated
May 11, 2021
Sponsor
Dr. Danielle Vicus
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1. Study Identification

Unique Protocol Identification Number
NCT03061435
Brief Title
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Acronym
Vulvar-AIN
Official Title
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Danielle Vicus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV-Related Anal Squamous Cell Carcinoma
Keywords
Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening anal Pap Smear - Negative (75%)
Arm Type
Other
Arm Description
All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.
Arm Title
Screening anal Pap Smear - Negative (25%)
Arm Type
Other
Arm Description
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.
Arm Title
Screening anal Pap Smear - Positive
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Screening anal Pap smear - No high-resolution anoscopy
Intervention Description
75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy
Intervention Type
Procedure
Intervention Name(s)
Screening anal Pap smear - High-resolution anoscopy
Intervention Description
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 Information:
Title
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 Outcome Measure Information:
Title
Prevalence of AIN in women with VIN 2/3 or vulvar cancer
Time Frame
6 months to 1 year
Title
Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN
Time Frame
6 months to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nithla Mohanathas, BSc
Phone
4164805000
Ext
85838
Email
nithla.mohanathas@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Anika Mohan, BSc
Phone
4164805000
Ext
89828
Email
anika.mohan@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Vicus, MD
Organizational Affiliation
Odette Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Danielle Vicus, MD

12. IPD Sharing Statement

Learn more about this trial

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

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