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Contact Information:

Prof Ranjit Manchanda
r.manchanda@qmul.ac.uk


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Be Part of Research - Trial Details - A population-based digital study offering people testing for cancer genes, to identify people at increased risk of cancer so they can take steps to prevent it or detect it early
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A population-based digital study offering people testing for cancer genes, to identify people at increased risk of cancer so they can take steps to prevent it or detect it early

Recruiting

Open to: Female

Age: Mixed

London

Medical Conditions

Cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


PROTECT-C is a research study offering genetic testing to people to see whether they have a genetic change that increases their risk of breast, ovary, bowel, and/or womb cancer. This is regardless of whether they or their families have had cancer.
Breast, ovary, bowel, and womb cancers make up half of all cancers in women. Around 15-20% (15 to 20 in 100 cases) of ovary and 3-4% (3 to 4 in 100 cases) of breast, womb, and bowel cancers are linked to cancer genes and may be prevented. People with a genetic change that puts them at increased risk of any of these cancers have ways to help them manage their risk through the NHS. This may include screening to find cancers earlier when they are easier to treat, and surgery or medication to prevent cancers from developing. This can save lives.
Currently, genetic testing is only available on the NHS to people who meet certain criteria. For example, those who have had certain cancers, have a strong family history of cancer, or those with Jewish ancestry. But many people may not have a strong family history or meet NHS testing criteria. This means that this system of testing misses 50% to 80% of people (50 to 80 in 100 people) who have a genetic change. It is thought that only around 3 in 100 people overall who have a genetic change that increases their risk of cancer know about it. Given the effective screening and preventive options that are available, this represents a huge, missed opportunity to prevent cancers or find them earlier.
Overall, the PROTECT-C study aims to evaluate the option of offering genetic testing to everyone who may want it. This is regardless of whether they or their families have had cancer. We will offer genetic testing to 5000 people. The study will test for genetic changes in nine cancer genes associated with breast, ovary, womb and bowel cancer. These genes include: BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, and MSH6.
Additionally, the study will use a complex mathematical algorithm to provide women with their personal risk of breast cancer and ovarian cancer.
The study will look at how many people decide to have genetic testing and how many of them are found to have a genetic change. The study will evaluate how many people with the genetic change would have been missed by standard NHS criteria. The study will evaluate how many women at increased risk are identified using a complex mathematical algorithm (called CANRISK).
It will evaluate their experience with using the study app and how this approach to genetic testing affects their quality-of-life, satisfaction, and mental well-being. This will give us a better understanding of how well the app works as a way of offering genetic testing to people.
The study is interested to see how people found to be at increased risk decide to manage their risk. We will assess the uptake of screening and prevention options.
Few participants will be invited to have 1:1 interviews by the study team. This will evaluate their experience of making a decision about genetic testing and taking part in the study. Taking part in these interviews is optional. The study will also assess if this way of offering genetic testing to people is affordable for the NHS.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Dec 2025 31 Dec 2029

PROTECT-C is a completely digital study. The study team will give participants access to an app developed specifically for this study. They can download this app using a smartphone or tablet or access it on any internet browser using a computer or laptop. Before they can access the app, participants will need to complete a consent form. They will also be asked to fill in a short questionnaire about themselves and their health.
The PROTECT-C app contains information including animation videos to help participants decide if they would like to have genetic testing (or not).
On the app, information is available about:
1. Genetic changes and cancer risk
2. Breast, ovary, bowel, and womb cancers
3. How genetic testing is performed
4. Possible advantages and disadvantages of testing
5. Other considerations of testing
6. Possible results of genetic testing
7. What the test results mean for them and their family
8. Ways to manage their risk
9. Cascade (family) testing
Participants can watch videos on the app that has been created to help them understand this information. These videos will also be translated into Bengali, Polish, Romanian, Punjabi and Urdu. When a participant feels ready to decide, they can make their decision about genetic testing on the app.
If they decide to have genetic testing, they will complete a consent form for genetic testing on the app. The study team will send them a saliva based test kit in the post. The study participant will return the saliva sample by freepost. Results will be returned to participants via the app and email, and by post if they wish.
Participants will be able to access support throughout the study by contacting a helpline (available via telephone, email, and an online booking system) staffed by specially trained counsellors experienced in cancer genetic counselling. Both technical and counselling support is available via the helpline.
If participants decide not to have genetic testing, they will not be sent a test kit in the post. They study team will ask participants to answer some questions about their experience with using the app and their reasons for not having testing. Participants will then exit the study, and no further action will be required.
Participants found to carry a genetic change or those with increased risk (positive) or VUS results will be given post-test counselling (virtual (e.g. via Teams) or telephone). This can be booked via an online booking system by the participants themselves, or the study counsellors will contact the participants directly and book an appointment. Participants at an increased risk will be referred to Clinical Genetics within the NHS and offered access to screening and prevention options in the NHS.
As part of the study, they study team will ask participants to fill in questionnaires about their health and lifestyle, history of cancer in their family, experience with using the app, and how genetic testing has affected them. The information they provide in these questionnaires is confidential.
Participants may be invited to have 1:1 interviews by the study team. This will evaluate their experience of making a decision about genetic testing and taking part in the study. Taking part in these interviews is optional.

Testing of family members or Cascade testing:
Participants who are found to have a genetic change in any one of the nine cancer genes tested for in the study can share this information with their family members. Family members too can be offered the opportunity through the study itself to find out if they have inherited this genetic change. This is called cascade testing.


Participants may take part if they:
1. Are over the age of 18 years and
2. Are a woman, trans man, or non-binary person with female reproductive organs (ovaries, fallopian tubes, and/or a uterus) and
3. Have never had genetic testing for the cancer genes tested for in the study and
4. Do not have first-degree family members (e.g.: parent, sibling, child) or second-degree family members (e.g.: aunt, uncle, niece, nephew, grandchild, grandparent, half-sibling) with genetic changes in the cancer genes tested for in the study

You can take part if:



You may not be able to take part if:


1. Individuals who have undergone genetic testing for one or more of the following CSGs: BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BRIP1, MLH1, MSH2, MSH62. First-degree relative (FDR) or second-degree relative (SDR) with a pathogenic or likely pathogenic variant (PV) in any of above CSGs3. Inability to provide informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Mary University of London
    Wolfson Institute of Population Health Queen Mary University of London, Charterhouse Square
    London
    EC1M 6BQ

If participants decide to take part, they will get the opportunity to learn more about genetic testing and cancer risk. They can also choose to have genetic testing to find out if they have a genetic change which increases their risk of breast, ovary, bowel, and/or womb cancer. They can provide the study team with a saliva (spit) sample in the comfort of their own home.
If a participant has genetic testing and find out that they are at increased risk of any of these cancers, they will be offered screening to find cancers earlier when they are easier to treat, and surgery or medication to prevent cancers from developing. This can save lives.
If a participant has genetic testing and find out that they have a genetic change in a cancer gene, their family members can be offered the opportunity to find out if they have a genetic change. This can be through the study itself or the NHS. Family member who are affected can also then opt for screening or prevention options to reduce their cancer risk.
By taking part, participants will be contributing to research for prevention and early detection of cancer. This may benefit other people in the future. The PROTECT-C study is looking to see if genetic testing for cancer genes can be offered to everyone in the population.
The PROTECT-C study team does not believe there are significant major risks of taking part in this study or receiving information about genetic testing. However, some people who are found to be at increased risk or carry an inheritable genetic change may feel emotionally upset, sad or guilty of passing this on to their children. They can discuss these issues with the study counsellor either before deciding to undergo testing should they wish. They will receive mandatory counselling support to help them following a positive result.

Prof Ranjit Manchanda
r.manchanda@qmul.ac.uk



The study is sponsored by Queen Mary University of London and funded by Yorkshire Cancer Research.



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Read full details for Trial ID: ISRCTN17289436

Or CPMS: 64677

Last updated 31 December 2025

This page is to help you find out about a research study and if you may be able to take part

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