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RecruitingNAINTERVENTIONAL

Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Using Vaginal Self-sampling and a Health Questionnaire

This study is for women in the UK who have Lynch syndrome and still have their womb. We want to see if a simple home test, where you collect a small sample from your vagina, can help doctors find early signs of womb cancer. We also want to find out if women are happy to collect these samples themselves and if they find the process easy to do. The study hopes to understand if changes in DNA from these samples can predict cancer risk. It also looks at whether a questionnaire used for other people can also help identify risk in women with Lynch syndrome. Taking part involves answering questions about your health and lifestyle, and collecting samples at home.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of British Columbia
Enrolment target
30
Start
29 Aug 2025
Estimated completion
01 Apr 2027

What is this study about?

This study is all about finding new and easier ways to check for womb (endometrial) cancer in women who have a condition called Lynch syndrome. Lynch syndrome is an inherited condition that increases your risk of developing certain cancers, including womb cancer. Currently, checking for womb cancer can involve procedures that some find uncomfortable or difficult.

The main idea behind this research is to see if women themselves can collect a simple sample from their vagina at home. Scientists can then look at the DNA in these samples for any early warning signs of cancer or conditions that might lead to cancer. The study also wants to know if women are willing and able to collect these samples themselves, and if they feel comfortable doing so. This is really important because if self-testing works and is accepted, it could make checking for cancer much easier and more convenient for many people.

We also want to find out if changes in the DNA from these self-collected samples can accurately predict who might be at higher risk of cancer. We're comparing this to other tests and looking at whether a health questionnaire, already used to assess cancer risk in the general population, can also be helpful for women with Lynch syndrome. Ultimately, the goal is to develop better, less invasive ways to monitor cancer risk and potentially catch any problems much earlier.

Key takeaways

  • This study is for women with Lynch syndrome who still have their womb.
  • It aims to find new, easier ways to check for early signs of womb cancer.
  • You will collect samples yourself at home using a simple kit.
  • Participation involves answering health questions and completing short surveys.
  • There are no clinic visits required, and no major risks involved.
  • Your involvement could help improve future cancer screening for others.

Who may be eligible?

To take part in this study, you must be a woman with Lynch syndrome. This means a genetic test must have already confirmed you have this condition. You also need to still have your womb (uterus) and be aged 30 or older.

However, some women cannot join the study. This includes if you have ever had womb cancer in the past, or a condition called endometrial hyperplasia (which means the lining of your womb has thickened more than it should). You also can't take part if you've had certain treatments like radiation therapy to your pelvis or a procedure called endometrial ablation. Lastly, if you are pregnant at the time or become pregnant during the study, you would not be able to participate.

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. I have been diagnosed with Lynch syndrome by a genetic test.
  2. I still have my womb (uterus).
  3. I am aged 30 or older.
  4. I have never had womb cancer or 'endometrial hyperplasia'.
  5. I have not had radiation to my pelvis or endometrial ablation.
  6. I am not currently pregnant or planning to become pregnant during the study.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to do a few things from the comfort of your own home. First, you'll complete a health questionnaire, which asks about your lifestyle and any symptoms you might have. Next, you'll receive a kit to collect samples yourself. This kit will allow you to take a vaginal swab and measure the pH (a measure of acidity) of your vagina. You'll do this at home following simple instructions.

Throughout the study, you'll also be asked to fill out a few short surveys. These will be about your experience collecting the samples and your thoughts about the process. You'll complete one around the time you collect your samples and a final one at the end of the study. There are no clinic visits required for this study.

Potential risks and benefits

There are no major risks linked to taking part in this study, as it only involves collecting samples at home and answering questionnaires. You might find the self-collection process a little unusual or slightly uncomfortable, but it should not be painful. The main potential benefit is that your involvement could help researchers learn more about early detection of womb cancer in women with Lynch syndrome, potentially leading to better screening methods in the future for many women. You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • VGH Research Pavilion
    Verified postcode
    Vancouver, Canada· Recruiting

Common questions

What is Lynch syndrome?

Lynch syndrome is a condition passed down in families that increases your risk of developing certain cancers, including cancers of the womb and bowel.

Will this study tell me if I have cancer?

No, this study is for research purposes only. It will not give you a diagnosis or tell you your personal cancer risk. It aims to find new ways to detect cancer early in the future.

Do I need to visit a hospital or clinic?

No, all parts of this study, including answering questionnaires and collecting samples, can be done from your home.

What is a 'vaginal swab'?

A vaginal swab is like a large cotton bud that you gently insert yourself to collect a small sample of fluid and cells from your vagina.

Is my information kept private?

Yes, all your personal information and study data will be handled confidentially and kept private, following strict data protection rules.

How to find out more

Aline Talhouk, 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 "Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Usi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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