"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at screening for anal cancer (ANALOGY)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
The anus is the part of the bowel that opens to the outside of the body. Cancer of the anus (anal cancer) can be caused by an infection called human papilloma virus (HPV). This is the same virus that can cause cervical cancer.
Anal cancer is rare in the general population, but some groups of people are at increased risk. This includes people who are HIV positive, people who have anal sex and people whose immune system has been affected by having an organ transplant such as a kidney transplant. These people are at higher risk of getting anal HPV, which increases their risk of anal cancer.
In this study, researchers are looking at the possibility of screening for anal cancer in these high risk groups. They want to
- See if people would find this type of screening acceptable
- Find out how well it works
Who can enter
You may be asked to join this study if you are over 25 years of age and are in 1 of the following 4 high risk groups
- HIV positive men who have anal receptive sex with men
- HIV positive women who have had genital warts or have previously had abnormal cells in their cervix, vulva or vagina
- HIV negative men and women who have anal receptive sex
- People who have had a kidney transplant
You will not be able to take part if you have had pre cancerous cells in your anus before, or if you are pregnant.
The study aims to recruit about 1,000 people all together.
If the study team talk to you about taking part, they will ask you to fill out a brief questionnaire. This will ask about your age, your sex, whether you are in a high risk group and any symptoms you have. There are also questions about your awareness of anal cancer and pre cancerous changes, and what you think about screening. If you decide you don’t want to take part in the study, it will ask if you are willing to say why not.
A member of the study team will put a small brush just inside your anus to take a sample of cells (a swab). This only takes a few seconds.
A doctor then looks at the inside and outside of your anus using a microscope. This is called anoscopy. It takes 2 to 3 minutes and is not painful. If the doctor sees an area that looks abnormal, or the swab shows you have HPV or abnormal cells, they will ask you to have a
If the biopsy shows you have cell changes that could lead to cancer, or that you have anal cancer, a specialist will talk to you about treatment.
Everybody will be asked to have a swab and anoscopy again 6 months later.
The number of extra hospital visits you have will depend on the results of the tests you have.
If you have a biopsy, the doctor injects a local anaesthetic into your anus. This stings when it is being injected, which takes 5 to 10 seconds. The biopsy itself should then be painless. There may be some bleeding afterwards and occasionally people need a stitch to stop this.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Henry Kitchener
Central Manchester University Hospitals NHS Foundation Trust
NHS Cancer Screening Programmes
NIHR Clinical Research Network: Cancer