EASY-CARE Trial
Welcome to the website for the EASY-CARE trial. The trial is looking at a new, less invasive test for the detection of womb cancer.
The new test is called the WID®-easy test. The trial will compare the new method with the current standard-of-care, which is ultrasound.
Taking part
If you agree to take part in the research, your clinic visit will include some additional steps:
- When you come to the clinic
- The WID®-easy swab test
- Next steps
- Optional questionnaire
- Your data
More information on each step is provided below.
The trial is entirely optional, and your decision won’t affect your care in any way.
You can find out more by watching the video or reading the participant information sheet.
Subtitles are available: click on the Settings button in the video screen to select your preferred language (English, Turkish, Somali, Romanian or Polish).
Türkçe altyazılı izlemek için: Video ekranındaki Ayarlar düğmesine tıklayın ve Türkçe’yi seçin.
Si aad ugu daawato qoraallo hoosaad Soomaali ah: guji batoonka Dejinta ee shaashadda muuqaalka oo dooro Soomaali.
Pentru a viziona cu subtitrări în română: faceți clic pe butonul Setări din ecranul video și selectați Română.
Aby oglądać z polskimi napisami: kliknij przycisk Ustawienia na ekranie wideo i wybierz polski.
A nurse will welcome you and explain the study.
If you decide to take part, you’ll be asked to sign a consent form, which means you agree to join the study.
When your doctor does a routine pelvic examination, they will use a swab to collect a small amount of fluid from inside your vagina, near the cervix (the neck of the womb). The sample will be sent for WID®-easy testing.
After the swab is taken, your appointment will continue as usual and you will have an ultrasound scan of your womb.
In a small number of cases, the WID-easy test might show a possible problem even when the ultrasound looks normal.
If that happens, you will be invited back to consider a hysteroscopy which is a camera test to double-check the lining of the womb as this could find a cancer the ultrasound missed.
As part of the trial, we will also invite you complete a short feedback questionnaire and participate in a 1:1 interview with our researchers.
Both of these activities are entirely optional.
During the trial, we will look at your health records and information from the National Cancer Registry after 3 months and 12 months to see whether you have developed any serious medical problems, including cancer.
All your personal information will be kept private and secure, and no genetic testing will be done on your samples.
Benefits
The direct benefit of taking part in this research is that the WID®-easy test has the potential to detect any womb cancers that may be missed by ultrasound, which is the current standard test you would be offered for investigation of abnormal bleeding.
The WID®-easy test could offer an accurate and more comfortable way to check for womb cancer than the tests currently used, meaning fewer people may need invasive procedures in the future.
Risks
When the doctor takes the sample for the WID®-easy test, you may experience a similar discomfort to a cervical screening smear test. No other risks are anticipated with the WID®-easy test, however, there could be an extremely rare possibility that unanticipated risks might occur, as this is a research study of a new test. If any new information about risks becomes known during the study, you will be informed promptly.
If your WID®-easy test shows a high risk result, or if your ultrasound scan is abnormal, then additional tests may be recommended which have their own potential risks. A high risk WID®-easy test result suggests an increased chance of cancer. The clinical team will discuss further what this may mean for you if your test comes back as high risk result.
With any diagnostic test, including ultrasound which is the current standard of care test, there is a small risk of getting a false result. If you have a false negative result, we anticipate that you would continue to have symptoms and would return to clinic and be reassessed.
If you have a false positive result, you will have had an additional test to determine whether you have cancer.
