UKCTOCS home page Trial design UK COLLABORATIVE TRIAL OF OVARIAN CANCER SCREENING Funding organisations Collaborative centres
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Please note that we are no longer recruiting volunters onto the trial as we have achieved our target of 200,000

  1. Ovarian Cancer � The Facts
  2. UKCTOCS - The Background
  3. Eligibility Criteria
  4. What Does Participation Involve?
  5. Control/Questionnaire Group
  6. Multimodal Group(blood test for CA125)
  7. Ultrasound Group
  8. Potential Disadvantages of Taking Part
  9. Are There Any Possible Benefits to Taking Part?
  10. Confidentiality/Data Protection Issues
  11. Questions and Answers on the Ovarian Screening Trial Prepared for Enquiries After The MRC Press Release



 

OVARIAN CANCER � THE FACTS

Ovarian cancer is the fourth commonest cause of death from cancer amongst women in the UK The majority of women who develop this cancer have few symptoms until it has spread outside the ovaries. By then, the cancer is much more difficult to treat and many women will die as a consequence of the cancer. In contrast, treatment is more successful and the outlook can be good for the small proportion of women diagnosed before the ovarian cancer has spread. The purpose of this study is to determine whether screening will detect ovarian cancer at an early stage when treatment is more effective and therefore reduce the number of deaths due to the disease.



 

UKCTOCS - THE BACKGROUND

 

Large studies performed by our research team and other international teams during the last decade have developed and refined two methods of screening. One method uses ultrasound scanning, similar to the scanning used in pregnancy, to check for any enlargement or abnormality of the ovaries. Ultrasound is currently widely used for diagnosing ovarian cancer in women with symptoms. It has been shown that the ultrasound test can be abnormal in the early stage of many ovarian cancers. This trial will use a method of ultrasound scanning called "transvaginal scan" whereby a probe is inserted into the vagina to see the ovaries. This method of scanning gives a much clearer picture of the ovaries than a transabdominal scan, where the probe is placed on the abdomen. The second method involves a blood test to measure a substance called CA 125. Most women who develop ovarian cancer have high levels of the protein called CA125 in their blood. The CA125 test is therefore currently used to diagnose ovarian cancer in women with symptoms and to monitor women after treatment. It has been shown that the CA125 test can be elevated in the early stage of many ovarian cancers. In addition, the research team believes that it may be possible to identify those women with early ovarian cancer where the CA125 blood test is not elevated by looking for changes i.e. increases in a woman's blood results over time.

Using these tests it seems likely that over 80% of women with ovarian cancer can be identified before they have symptoms. This current very large trial will answer the question whether early detection of ovarian cancer, using these tests can save the lives of women who have ovarian cancer.

Because we do not know if either of the screening methods are able to save lives from ovarian cancer we need to compare both methods of screening with a group of women who will not be screened. This will tell us whether screening can save lives and which method is most effective. This is called a randomised trial. The groups are randomly selected by a computer. Of the 200,000 women who agree to participate half will be screened every year for 6 years and half will be in the control group and followed up with questionnaires without screening. Overall the study will take 10 years to complete. Each participant will be followed up for 6 years. Of the 100,000 women who will be screened 50,000 will be screened with ultrasound and 50,000 with the CA 125 blood test.

The study will also assess the cost implications of the screening methods to the National Health Service (NHS), what anxieties and fears being screened may raise and what complications might arise as a result of screening. This information will be used to make a decision about whether an NHS national screening programme for ovarian cancer should be introduced.

The results will be reviewed by other medical professionals and published in the medical press. Results will probably only be available within a 12 year period. Should either screening method prove to be of benefit the results will be presented to the government as a case for a national screening programme to be implemented. Participants will be notified in writing that the study has been completed and of the outcome. Individuals will not be identified in any publications.



 

ELIGIBILITY CRITERIA � SEE OTHER SECTION

 





 

WHAT DOES PARTICIPATION INVOLVE?

 

Women who agree to take part in this study will be sent an information leaflet and an appointment to attend their regional centre for registration. At this appointment, the study will be discussed in greater detail and they will have the opportunity to ask any questions. Women who agree to participate will be asked to sign a consent form. A questionnaire will be completed and eligibility confirmed. A blood sample will be taken. Their General Practitioner will be informed of their participation.

A further questionnaire will be given for completion at home and return by post to assess the psychological implications of screening and the perception of risk of ovarian cancer. This should not take more than 10 minutes to complete. A small number of women, including those who have abnormal results on screening, will be sent repeat questionnaires which also assess the acceptability of the screening methods to complete at home during the course of the study.

For women allocated to either screened group there is no special preparation for either the blood test or the ultrasound scan.



 

CONTROL/QUESTIONNAIRE GROUP

Women allocated to the group not to be screened will be asked to complete health related questionnaires 3.5 and 7 years after recruitment. The questionnaires will be sent to their home for completion and they will not be required to attend any further appointments. We will request their GP to refer them to the same specialist at the regional centre as women who are allocated to the screened groups if at anytime they develop symptoms that raises the possibility of ovarian cancer. They will not be asked to have further blood tests or an ultrasound scan. The blood test taken at the registration visit will not be tested at this time but will be stored to be used at some stage in the future to assess potential tests for cancer. As these will be tests in the initial phases of being researched, the results will not be conclusive and therefore they will not be notified of the results. Women allocated to this group are vital to the outcome of the study.



 

MULTIMODAL GROUP (BLOOD TEST FOR CA125)

 

The blood sample taken at the registration visit from women allocated to the CA125 group will be tested. Their potential risk of developing ovarian cancer (ROC) in the year following the blood test will be calculated. The ROC will be recalculated after each blood test. The ROC calculation is looking for changes in blood results over time. For this reason the recommended follow-up may vary during the course of the study but will be one of the following:

 

 



 

ULTRASOUND GROUP

 

Women allocated to the ultrasound group will be sent an appointment for a scan of their ovaries. If no abnormalities are detected on the scan they will be sent an appointment for a further scan in one year. If an abnormality is seen, those women will be sent an appointment for a repeat scan in 6-8 weeks. This is because many of the abnormalities will disappear on their own and need no treatment. If the repeat scan is normal those women will be recalled in one year. If the repeat scan shows that the changes seen in the first scan persist, they will be referred to a specialist at the regional centre for further tests and surgery to remove the ovaries. This will be arranged in consultation with the woman and their General Practitioner. Only 1 in 10 of the women who have an abnormality detected at ultrasound and have surgery will have ovarian cancer. The others will usually have non cancerous conditions of the ovary.

The blood test taken at the registration visit will not be tested but will be stored to be used at some stage in the future to assess potential tests for cancer. As these will be tests in the initial phases of being researched, the results will not be conclusive and therefore women will not be notified of any results.

Women will be notified by post of their recommended follow-up after every blood test or investigation.

 

 

 



 

POTENTIAL DISADVANTGES OF TAKING PART

 





 

ARE THERE ANY POSSIBLE BENEFITS OF TAKING PART?

 





 

CONFIDENTIALITY/DATA PROTECTION ISSUES

 

What if new information becomes available? There is an independent Data Monitoring and Ethics committee that will assess the trial on an ongoing basis. If any information should become available that makes this study unethical, then this committee will recommend to the Trial Steering Committee which also has an independent chairman and non medical representatives that the study be stopped.

Will taking part in this study be kept confidential? All information which is collected about participants during the course of the research will be kept strictly confidential. Occasionally the research documentation and results will be looked at by the people funding the research programme to check that the study is being carried out properly. Any information about participants which is viewed by people not directly related to the research team will have names and addresses removed so that women cannot be recognised from it.




 

QUESTIONS & ANSWERS

 

 

 

 

 

 

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Last updated 01.04.19