RecruitingNAINTERVENTIONAL

STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

This study is exploring new ways to treat early-stage vulvar (outside of the vagina) cancer. Doctors want to find out if understanding more about the cancer, specifically if it's caused by the Human Papilloma Virus (HPV) or has certain other features (linked to something called p53), can help decide the best treatment plan. Currently, most people with early vulvar cancer have surgery. This study aims to see if some people might need less surgery, or if others might need more targeted treatment, based on these new test results. The goal is to make sure each patient gets the right amount of treatment for their specific cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Canadian Cancer Trials Group

Enrolment target

249

Start

10 Dec 2024

Estimated completion

30 Nov 2031

Vulvar Squamous Cell Carcinoma

What is this study about?

Imagine you have early-stage vulvar cancer. Normally, the main treatment is surgery. But what if we could be smarter about it? That's what this study is all about. We're trying to figure out if there are different types of early-stage vulvar cancer that might need either less treatment than usual, or perhaps a slightly different approach.

The study focuses on understanding your cancer better by looking at two key things: whether it's caused by the Human Papilloma Virus (HPV) and another specific characteristic, known as p53 status. When you have surgery, the removed tissue is usually studied in a lab. In this study, we'd do extra tests on that tissue to see if HPV caused the cancer or not. Depending on what these lab tests show, different treatment paths might be suggested.

For example, if your cancer is caused by HPV, the study might suggest carefully watching the area without further surgery. If your cancer is not caused by HPV, the study will look at whether you have a second surgery or are also carefully watched, to see which approach works best. The aim is always to find the safest and most effective way to care for you, tailored to your specific cancer type.

Key takeaways

This study aims to find better ways to treat early vulvar cancer.
It uses lab tests (for HPV and p53) to help guide treatment decisions.
Some patients might have less surgery if these tests show it's safe.
Participation involves initial surgery, special lab tests, and careful monitoring.
You will also complete questionnaires about your wellbeing.

Who may be eligible?

To join this study, you must be at least 18 years old and have been diagnosed with a specific type of early vulvar cancer called squamous cell carcinoma. This diagnosis needs to be confirmed by lab tests. You also need to have had initial surgery following standard guidelines, and the doctors need to have checked the edges of the removed tissue carefully.

It's important that you haven't received any strong treatments like radiation or chemotherapy for vulvar cancer before. Also, your cancer should not have spread to your lymph nodes, and you shouldn't have had vulvar cancer come back after previous treatment. You'll also need to be able to understand and fill out some questionnaires in English or French.

There are also some other specific reasons why you might not be able to join, such as having certain other types of cancer in the past (unless they were fully treated a long time ago) or if the first surgery didn't completely remove the cancer at its edges.

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 at least 18 years old?
Have you been diagnosed with early-stage vulvar squamous cell carcinoma?
Have you had initial surgery for this cancer, following standard guidelines?
Have you NOT had previous radiation or chemotherapy for vulvar cancer?
Is your cancer NOT currently in your lymph nodes or a recurrence (cancer coming back)?
Can you complete questionnaires in English or French?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is that your initial surgery for vulvar cancer would be done as usual. After this, the tissue removed during your surgery will be sent for special lab tests to check for HPV and another marker called p53. Based on these specific test results, your study doctor will suggest which treatment path is best for you within the study.

You would either be in a group that receives no additional surgery but is carefully monitored, or a group that might receive a second surgery, or also be carefully monitored without more surgery. The study aims to compare these approaches. Throughout the study, you would have regular check-ups with your doctor. You would also be asked to fill out questionnaires about your quality of life. The total duration of your participation would be discussed with you by the study team.

Potential risks and benefits

Taking part in a study like this means you might be among the first to benefit from a new approach to treatment, potentially reducing the amount of surgery you need. However, there are also potential risks involved, as the new approaches are being compared to standard care. For example, if you are in a group that doesn't have immediate follow-up surgery, there's a small chance the cancer might return sooner. You will be closely monitored, and your doctor will discuss all potential risks and benefits with you in detail. Remember, you can always choose to leave the study at any time without affecting your usual medical care.

Locations (11)

BCCA - Kelowna
Verified postcode
Kelowna, Canada· Recruiting
BCCA - Vancouver
Verified postcode
Vancouver, Canada· Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Recruiting
Odette Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
University Health Network
Verified postcode
Toronto, Canada· Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Verified postcode
Montreal, Canada· Recruiting
The Jewish General Hospital
Verified postcode
Montreal, Canada· Not yet recruiting
Hotel-Dieu de Quebec
Verified postcode
Québec, Canada· Recruiting
CIUSSS de l'Estrie - Centre hospitalier
Verified postcode
Sherbrooke, Canada· Recruiting
Allan Blair Cancer Centre
Verified postcode
Regina, Canada· Recruiting
Auckland City Hospital
Verified postcode
Auckland, New Zealand· Recruiting

Common questions

What is vulvar squamous cell carcinoma?

It's a type of cancer that starts on the outer part of a woman's genitals, called the vulva. Squamous cell carcinoma is the most common kind of vulvar cancer.

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

HPV stands for Human Papilloma Virus. It's a common virus, and some types can cause certain cancers, including some vulvar cancers. This study is looking at whether knowing if HPV caused your cancer can help decide the best treatment.

What does 'active surveillance' or 'observation' mean?

It means doctors will carefully watch your condition with regular check-ups and tests, instead of giving you more treatment right away. It's used when there's a low risk of the cancer coming back or spreading quickly.

Will I definitely have less surgery if I join this study?

Not necessarily. The study is trying to find out if certain types of vulvar cancer might need less surgery. Depending on your lab results, you might still have a second surgery, or you might be in a group that is just watched closely.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Wendy Parulekar

wparulekar@ctg.queensu.ca 613-533-6430 Official trial record

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