A study looking at two different ways of carrying out genetic testing for people with cancer (DETECT-2)

Cancer type:

Bowel (colorectal) cancer
Ovarian cancer
Womb (uterine or endometrial) cancer

Status:

Open

This study is comparing genetic testing at home with genetic testing in hospital.

It is open to people with:

  • bowel (colorectal) cancer
  • womb (endometrial) cancer
  • ovarian cancer

More about this trial

Some people that develop cancer have gene changes (mutations Open a glossary item) that doctors can test for. Knowing whether you have a gene change helps doctors work out what is the best treatment for you.

Information about gene changes might also be useful to know for you and your family. It might be that there is an inherited cancer gene change in your family. And some family members might be offered similar genetic testing as a result.

To have a gene test, the doctor will usually arrange a clinic appointment for you. In the clinic you see a member of your cancer team. They will discuss testing with you. This will include how they do it as well as the advantages and disadvantages of having the test. To do the testing they take a blood sample and send it to the laboratory. 

In this study, the team are looking at how patients feel about genetic testing at home. This is called direct to patient testing. Direct to patient testing uses an app Open a glossary item.

This app helps people to decide whether they want genetic testing or not. It can also arrange a way of taking the test sample without going to the hospital clinic. Instead of giving a blood sample the team ask for a spit (saliva) sample. The saliva genetic test is as good as the blood genetic test. 

The main aims of this study are to find out:

  • how many people are willing to use the app and have genetic testing at home compared to testing in hospital
  • what people think about their genetic testing and if they find this acceptable

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if you are at least 18 years old and one of the following apply. You have:

       or

       or

You must also have online access and email access. 

Who can’t take part

You cannot join this study if either of these apply. You:

  • have had previous genetic testing for Lynch syndrome Open a glossary item or for any ovarian cancer genes 
  • have certain known gene changes that are in your family. Your doctor will know which gene changes these are. 

Trial design

The team need 832 people to take part. When you agree to join the study, you fill in a questionnaire. The questions ask about your:

  • lifestyle
  • medical history Open a glossary item 
  • family history Open a glossary item
  • physical wellbeing 
  • mental wellbeing

This takes about 20 minutes to do. These can be done either on paper or online.

This is a randomised study. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you go into. The 2 groups are:

  • direct to patient testing 
  • testing in the hospital

Direct to patient testing
The team gives you access to the app Open a glossary item. You can access the app on a smartphone, tablet or computer. To help you decide if you want to have genetic testing, the app has information and animations about genetic testing. You can take your time to read through the information. You can read it either by yourself or with someone else such as a family member or friend. 

There is a telephone helpline you can call if you have any questions or would like further support. The person you talk to is a specially trained counsellor who is part of the study team. 

You then accept or decline the genetic testing online. When you have done so, you fill in a questionnaire on how you feel about your decision. People in the direct to patient testing will also be asked about any app or helpline they used. This takes about 10 minutes.

If you agree to have genetic testing
The team will post out a saliva collection kit to you. The kit contains all the instructions and equipment you need to do this. You collect a sample of spit (saliva) by spitting into a tube that you post back to the laboratory. The team provides an addressed return envelope for you to do this. In the laboratory they test this sample for the gene changes. 

The team might ask you to do the spit collection again if:

  • there isn’t enough spit to do the test
  • there is a problem processing the spit sample at the laboratory 

They will only ask you to repeat this once. If this is unsuccessful again, they will ask if you are willing to have a blood sample taken for the testing. If you say yes, the team will send you a blood sample kit. You take the kit to either your cancer clinic or your GP. They will take the blood sample and send it to the laboratory. 

If you decide not to have the genetic testing, you can tell the study team or withdraw from the study. 

You receive the results of the genetic testing by post and email. The results will explain one of the following:

  • you do have a gene change that causes cancer
  • you have a gene change but it is not clear whether this change causes cancer
  • you don’t have a gene change that can cause cancer

If you do have a gene change, the team will ask you to call the telephone helpline. The study counsellor will discuss with you what the results mean and answer any questions you have. 

The counsellor will contact you by post or email if you have not contacted the helpline after about a week. This is to make an appointment to have this discussion. 

They will also send the results of the testing to your healthcare team and your GP.

Testing in hospital
This is the usual way genetic testing happens. You get information about genetic testing from a member of your healthcare team. They will discuss it with you and answer any questions you have. You fill in a consent form if you agree to have the testing done. 

If you agree to have genetic testing 
Most hospitals take a blood sample to do the genetic testing.

You get the results of the testing from your cancer care team. They will discuss what the results mean for you. They will also send the results of the testing to your GP.

Interviews for those in both groups who agree to have genetic testing
The team might ask if you are willing to take part in an interview. This will be between 1 and 6 months after getting your results. The interview will be over the phone or as a video call. The team can arrange it at a time convenient to you. 

The interviewer will ask about your:

  • thoughts and views about genetic testing
  • experience of genetic testing

You don’t have to do the interview. You can still take part in the study.

Quality of life for those in both groups who agree to have genetic testing
You fill in questionnaires:

  • before you have your genetic testing
  • 3 weeks after receiving the test results
  • 6 months after receiving the results
  • 1 year after receiving the results

The questions ask about:

  • your general health and wellbeing
  • your quality of life
  • how satisfied you are with the decision about doing the testing

These are quality of life questionnaires.

If you decide not to have genetic testing in either group
You fill in a questionnaire about why you decided not to have the genetic testing.

For those who are in the direct patient testing group there are also questions about your experience of using the app.

This will take about 5 minutes.

Hospital visits

There are no extra visits to the hospital if you take part in this study. 

Side effects

Having a genetic test to see whether you have a gene that could cause cancer might make you feel:

  • angry
  • sad
  • frightened
  • upset

You can talk to the specially trained counsellor about your feelings when you receive your results.

We have more information about inherited cancer genes and increased cancer risk.

Location

Cardiff
London
Romford

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Ranjit Manchanda

Supported by

Barts Charity
GlaxoSmithKline (GSK)
National Cancer Research Institute (NCRI)
North East London Cancer Alliance
North Central London Cancer Alliance
Queen Mary University of London
 

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19361

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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