RecruitingNAINTERVENTIONAL

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

This study is for women over 40 who have had or currently have specific vulvar (outer female private part) conditions, like certain pre-cancerous cells or vulvar cancer. The researchers want to find out if these women are also more likely to develop pre-cancerous changes or cancer in the anal area. Currently, there isn't a routine screening test for anal cancer in women, even though many get a similar test for cervical cancer. The study will involve a simple Pap test for the anal area, and if any changes are found, further checks will be done. The goal is to see if regular anal screening could be helpful for this group of women to catch and treat problems early.

At a glance

Status

Recruiting

Phase

Sponsor

Dr. Danielle Vicus

Enrolment target

110

Start

01 Feb 2021

Estimated completion

01 Jan 2026

Vulvar Cancer Cervical Cancer Vulvar Dysplasia Cervical Dysplasia Anal Cancer Anal Dysplasia HPV-Related Anal Squamous Cell Carcinoma

What is this study about?

This research is looking at why some women might be at higher risk for anal cancer. Many women will get an infection called HPV at some point in their lives. While most of the time this infection goes away on its own, sometimes it can cause changes in cells that could lead to cancer, not just in the cervix (the neck of the womb), but also in the vulva (the outer part of the female private area) and the anus (the opening where poo leaves the body).

Right now, women regularly get Pap tests to check for changes in their cervix, which can help prevent cervical cancer. However, there isn't a similar routine screening test for anal cancer, even though some studies suggest that women who have cell changes or cancer in their vulva might have a higher chance of developing similar problems in their anus. This study wants to explore this link further.

The main idea is to see if offering a simple anal Pap test to women over 40 who have had certain vulvar conditions could help find pre-cancerous cells or early anal cancer. If enough evidence is gathered, it could lead to changes in how doctors screen for anal cancer, helping to protect more women from this disease.

Key takeaways

This study is for women aged 40 or over.
It focuses on women who have had certain vulvar pre-cancerous changes or vulvar cancer.
It aims to see if regular anal screening could help find problems early in this group.
You would have an anal Pap test, and possibly a closer look (HRA) if needed.
Any pre-cancerous cells found would be treated.
This research could help improve future screening for anal cancer.

Who may be eligible?

This study is looking for women aged 40 or older. To be part of the study, you must have previously been diagnosed with either specific pre-cancerous changes in your vulva (called VIN 2/3) or vulvar cancer.

There are certain reasons why you wouldn't be able to join the study. You can't take part if you've been diagnosed with any type of cancer before, except for very common basal cell skin cancer, cervical cancer, or vulvar cancer. This is because these other cancers could make it harder for the researchers to understand the results related to vulvar and anal health.

You also can't participate if you have HIV (Human Immunodeficiency Virus), or if you are currently taking medications that weaken your immune system. Finally, if you have had an operation to remove your womb called a hysterectomy, you won't be able to join this study. These conditions might affect the study's results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Have you been diagnosed with VIN 2/3 (specific pre-cancerous vulvar cells) or vulvar cancer?
Do you currently have HIV or take immune-suppressing medication?
Have you had any cancer besides basal cell skin cancer, cervical cancer, or vulvar cancer?
Have you had a hysterectomy (womb removal operation)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors will perform an anal Pap smear. This is similar to a cervical Pap test but collects cells from your anal area. If this test shows any abnormal cells, you will then have a procedure called High-Resolution Anoscopy (HRA). During an HRA, a doctor uses a special magnifying scope to get a closer look at the anal lining. If any areas look suspicious during the HRA, the doctor may take small tissue samples (biopsies) for further testing. If pre-cancerous cells are found during these checks, you will receive appropriate treatment. The study aims to look at your anal health and any necessary treatments over a period of time, though the exact duration isn't specified, it would involve initial screening and follow-up if abnormalities are found.

Potential risks and benefits

Taking part in this study may offer the benefit of identifying and treating any pre-cancerous or cancerous cells in your anal area early, potentially before they cause more serious problems. However, there are some risks, such as discomfort during the anal Pap smear or HRA, and a very small risk of bleeding or infection from any biopsies taken. It's important to remember that you are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Odette Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is HPV and why is it important for this study?

HPV is a very common virus. For some people, it can cause cell changes that may lead to certain cancers, including anal, cervical, and vulvar cancer. This study looks at whether women with HPV-related vulvar changes are at higher risk for anal cell changes too.

What is an anal Pap smear?

It's similar to a cervical Pap smear, but it involves gently collecting cells from the anal area for laboratory testing. It helps check for any unusual cell changes.

What is High-Resolution Anoscopy (HRA)?

If your anal Pap smear shows unusual cells, an HRA is a closer look at the anal lining using a special magnifying scope. The doctor can see if there are any areas that need further investigation or treatment.

Will I get treatment if pre-cancerous cells are found?

Yes, if pre-cancerous cells are found, you will receive the appropriate treatment to remove them. The goal of the study is to find and treat these problems early.

Who is funding this study?

The information provided doesn't state who is funding the study. You can ask the research team for more details if you are interested.

How to find out more

Nithla Mohanathas, BSc

nithla.mohanathas@sunnybrook.ca 4164805000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.