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RecruitingNAINTERVENTIONAL

Host Genome Methylation: a Screening Tool in Anal Cancer Detection

This study is exploring a new, simpler way to screen for anal cancer, using an at-home test. Following new French guidelines for anal cancer screening, researchers are focusing on identifying people at higher risk. Currently, some screening methods can be complex and hard to access. This research aims to see if looking for specific 'methylation markers' (changes in your genes that can be linked to cancer) in a self-collected anal smear could help. If these markers are found, it might mean someone needs more detailed checks, potentially reducing unnecessary follow-up appointments for others. This could make screening more efficient and easier for people who are already considered at risk, like men who have sex with men living with HIV, and women with a history of certain cancers or who have had organ transplants.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
770
Start
22 Nov 2024
Estimated completion
22 Nov 2028

What is this study about?

Anal cancer is a type of cancer that develops in the back passage. While it's generally rare, some groups of people have a higher chance of getting it. Recently, doctors in France released new advice on who should be screened for anal cancer and how to do it. This was an important step because it was the first time a country issued such broad recommendations. However, some of the recommended follow-up tests, like a high-resolution anoscopy (HRA), require special equipment and experts which aren't always easy to find. This means that access to these important checks can be limited for some people.

This study is trying to find a better way to decide who really needs these more detailed tests. Researchers have previously found certain genetic markers, called ZNF582 and ASCL1, in anal smear samples. They noticed that these markers were more active (a process called 'methylation') in people who later developed anal cancer. The idea is that if these markers are present, it could be a warning sign, suggesting that person might need a closer look.

The main goal of this project is to test if these genetic markers can help sort people into groups: those who are genuinely at high risk and should have further checks like an HRA, and those who are at lower risk and might not need such detailed follow-ups. This could make the screening process much more efficient and less stressful for patients. Ultimately, the hope is to make anal cancer screening more accurate and accessible for everyone who needs it, helping to catch cancer earlier when it's often easier to treat.

Key takeaways

  • This study is testing a new home-based anal cancer screening method.
  • It aims to use genetic markers from a simple self-sample to identify high-risk individuals.
  • The goal is to make anal cancer screening more efficient and accessible.
  • It focuses on people already at higher risk according to new French guidelines.
  • Participation involves a self-collected anal smear and a questionnaire.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older. To join, you must be in a group that is currently recommended for anal cancer screening by new French guidelines. This includes men who have sex with men (MSM) over 30 and living with HIV, women who have had certain types of pre-cancerous spots or cancer in their private parts (like the vulva), or people who have had an organ transplant more than 10 years ago.

There are also some reasons why you wouldn't be able to join. You can't take part if you are currently being followed up for a serious anal lesion or cancer, or if you are pregnant or breastfeeding. Also, if you are unable to freely agree to participate (e.g., if you are in prison or under certain legal protections) or if you simply don't want to take part in the study, you wouldn't be eligible. Lastly, you must be affiliated with the social security system.

Finally, if you are unwilling to do an anal self-sampling test at the start of the study, you won't be able to participate. This test is a key part of the research.

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.

  1. Are you 18 years old or older?
  2. Are you a man who has sex with men (MSM), over 30, and living with HIV?
  3. Have you had an organ transplant more than 10 years ago?
  4. Are you a woman with a history of vulvar lesions or vulvar cancer?
  5. Are you willing to perform an anal self-sampling test?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide an anal smear sample yourself, in a similar way to how some women do cervical screening at home. You will also fill out a questionnaire about HPV (Human Papillomavirus), which is a common virus that can sometimes lead to anal cancer. The researchers will then analyse your self-taken sample for the specific genetic markers they are interested in. The study aims to see how well these markers predict who might need further checks. There are no medications involved in this study. The total duration of your participation would involve these initial steps, with no regular follow-up visits specifically for this research.

Potential risks and benefits

Potential benefits of taking part include helping researchers develop a safer, simpler, and more efficient way to screen for anal cancer, which could lead to earlier diagnosis. This could ultimately improve treatments and outcomes for many people. There are very few direct risks associated with providing a self-sample, which is generally a simple procedure. You might find it a little uncomfortable, but serious complications are unlikely. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (9)

  • Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Active not recruiting
  • Dermatology Department
    Verified postcode
    Paris, France· Not yet recruiting
  • Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Recruiting
  • Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Active not recruiting
  • Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Recruiting
  • Nephrology Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Active not recruiting
  • Pathological Anatomy and Cytology Department Bichat-Claude Hospital
    Verified postcode
    Paris, France· Active not recruiting
  • Pulmonology B and Lung Transplantation Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Active not recruiting
  • Virology Department Bichat-Claude Bernard Hospital
    Verified postcode
    Paris, France· Active not recruiting

Common questions

What is anal cancer and why is screening important?

Anal cancer is a type of cancer that affects the back passage. Catching it early through screening means it's often easier to treat and can lead to better health outcomes.

What are 'methylation markers'?

Methylation markers are like tiny tags on your DNA (your genetic code). Changes in these tags can sometimes be linked to the development of cancer, and researchers are studying if they can be used as a warning sign.

What is an anal self-sampling smear?

It's a simple test where you collect a sample from your back passage yourself, similar to how some women perform cervical screening at home. It's usually straightforward and not painful.

Who is considered 'at-risk' for anal cancer?

People at higher risk include men who have sex with men living with HIV, women with a history of certain private part cancers (like vulvar cancer), and people who have had an organ transplant a long time ago.

Will I get my test results from this study?

The study aims to develop a new screening tool for the future, and individual results from the research tests are usually not shared directly with participants. Your existing healthcare team will continue to manage your care.

How to find out more

Valentine FERRE, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Host Genome Methylation: a Screening Tool in Anal Cancer Det…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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