Why am I being asked to take part in this trial?
You are being asked to take part in this trial because you are having a routine Cervical Screening Test at a medical practice which has agreed to recruit women for the Compass Trial.
You can be part of this trial if you are:
- An Australian Resident
- Born on or after 1 July 1980 AND aged at least 25
- Attending for a Cervical Screening Test
- Not already enrolled in the Compass Trial Pilot Study
If you have symptoms which might suggest cervical cancer, you are not eligible for this trial.
Please read this information carefully and ask your health practitioner questions about anything you don’t understand.
If you decide you want to take part in the Compass Trial, you will be asked to sign the consent form.
By signing it you are telling us that you:
- Understand what you have read
- Agree to take part in the trial
- Agree to have the tests and treatments that are described
- Consent to the use of your personal and health information as described
You are under no obligation to take part in this trial. If you think you would like to take part and then change your mind you can withdraw at any time by calling 1800 611 635.
What does taking part in the trial involve?
In this trial we want to compare different cervical screening methods (HPV tests and Pap tests).
Your health practitioner will take your Cervical Screening Test in exactly the same way as usual, but will put the cells in liquid instead of placing them on a glass slide. This sample (called liquid-based cytology or LBC) will be sent to the laboratory. At the lab your sample will be put in one of two trial groups for testing. The groups will be randomly selected by a computer, so you cannot choose which group you are in.
Group 1: Women in this group will have a Pap test made from the cells in the fluid.
- If your Pap test is negative (no abnormal cells are seen) you will be asked to come back in 2 ½ years (30 months)
- If minor cell changes are seen you will be asked to come back in 1 year
- If more serious cell changes are found you will be asked to see a specialist
Groups 2: Women in this group will have an HPV test from the cells in the fluid.
- If your HPV test is negative you will be asked to return in 5 years (Note: As part of the safety-monitoring arm there is the possibility that you will be recalled to have a Pap smear at 2 ½ years instead of 5 years.)
- If the HPV test is positive you will be put into either group 2A or group 2B. We will use different methods of looking for HPV in each of these groups
Once your health practitioner has your results they will let you know what follow-up is required.
If you are asked to see a specialist he/she will do a colposcopy. This involves examining your cervix more closely with a magnifying instrument. If any treatment is needed the specialist will discuss this with you.
The Compass Registry will remind you when your next test is due, generally by writing to you 3 months before the due date. We also ask that you provide your email and mobile phone number so that the Compass Registry can contact you the next time your cervical screening test is due. You can still participate in the Compass Trial if you do not provide your mobile phone number or email.
For your health and safety it is very important that you follow all instructions about follow-up and treatment from your practitioner.
If at any stage you have any questions about the trial you can contact the trial hotline on 1800 611 635.
A Data Safety Monitoring Board and a safety-monitoring arm will both make sure that the trial is conducted in a safe manner.
There is no cost to you for participating in the trial apart from the usual cost for the medical consultation. You will not receive any payment for taking part in this trial.
In this trial:
- Women who have a negative Pap smear will not need to return for another Pap smear for 2 ½ years
- Women who have a negative HPV test will not need to come back for cervical screening for up to 5 years
An abnormal Pap smear result or a positive HPV test distresses some women. Make sure you discuss all results with your practitioner. For more information see What do my results mean?
What happens if I no longer want to participate?
You are under no obligation to participate in this trial. If at any stage you wish to withdraw from the trial you may do so by calling 1800 611 635 You can be assured that this will not affect the medical care you receive from your health practitioner.
In the event that you decide to withdraw from the Compass trial, then it is important for you to continue to participate in the National Cervical Screening Programme by resuming regular cervical screening using the Cervical Screening Test, currently recommended every five years.
If you choose to withdraw you will be sent a reminder for your next cervical screening test by the National Cancer Screening Register, according to the National Cervical Screening Guidelines. All data collected as part of the Compass Trial will be kept permanently as part of your test record at VCS Pathology and on the Compass Register.
If you withdraw from the Compass Trial, researchers will not use your information in any future data analysis for the Compass Trial. For more information on how your data is stored please visit www.vccr.org/privacy and http://www.vcspathology.org.au/women/privacy-statement
Do I still need regular Cervical Screening Tests?
Participation in the Compass trial replaces routine Cervical Screening Tests. Therefore you should not have additional Cervical Screening Tests whilst you are participating in the Compass trial.
In the event that you decide to withdraw from the Compass trial, then it is important for you to continue to participate in the National Cervical Screening Programme by resuming regular Cervical Screening Tests, currently recommended every five years.
How will I know when I need my next screening test?
Wallet card reminder
When you receive your results we hope that you are also given or sent a purse-sized card to keep with you to remind you when your next test is due. It explains when you are due for another test, and reminds your practitioner what to do. If you did not receive one of these cards, please contact the Compass trial staff on 1800 611 635 and we will send you one.
Reminders sent by the Pap Test Registry
Women participating in the Compass trial will be sent a reminder from the Compass Registry three months before they are due for their next screening test.
In addition to maintaining contact through mail, the Compass Register may contact you by mobile phone or by email
Change of address
If you move it is important to notify us of your new address by calling the Compass trial staff on 1800 611 635 or by sending an email to the Compass trial staff.
Where can I find more information on the HPV Vaccine?
For more information on the HPV Vaccine please visit http://www.hpvvaccine.org.au/
What is a colposcopy?
A colposcopy is a medical examination in which a specialist looks closely at the cervix using a special microscope for magnification. If an abnormal area is seen a tiny sample of cells is taken. This is called a biopsy. These cells are sent to the laboratory for further tests.
Having a colposcopy is just like having a Cervical Screening Test, but it takes longer; usually about 10-15 minutes. It can be done in the doctor’s clinic. If a biopsy is taken then your health practitioner will get the biopsy report within a week. They will then be able to discuss with you whether you need treatment and, if so, what type of treatment if best for you.
What do my results mean?
Human Papillomavirus (HPV) and Cervical Screening
We now know that infection over many years with certain types of Human Papillomavirus (HPV) is the main cause of cervical cancer.
There are around 40 types of HPV which can infect the genital area (including the cervix). Genital HPV is spread by genital skin-to-skin contact during sex. Most people will have genital HPV at some time in their lives but never know as there are usually no symptoms and, most often, the virus goes away on its own without causing any problems.
An abnormal Pap test is often due to infection with HPV. The Pap test can find changes in the cells of the cervix before serious problems develop. These cell abnormalities can also be predicted using the HPV test, which detects the virus itself.
- Negative (Normal), HPV test
- Negative (Normal), ThinPrep – Pap test
- HPV infection
- Cell changes that may require treatment
Information collected for this trial will be kept strictly confidential, in accordance with privacy laws. Only authorized staff will have access to the trial data which will be stored in a password protected database at VCS and Cancer Council NSW for the duration of the trial and for a period of at least 10 years after the completion of the trial.
Results from this trial will be published in a series of scientific papers. You and any information collected about you will not be identifiable directly or indirectly in any of these publications.
If you have any questions or concerns about this trial, please do not hesitate to contact Compass trial staff on 1800 611 635 or email email@example.com
What happens to my personal information?
VCS Foundation appreciates that it holds sensitive personal health information. We have strict confidentiality practices in place to protect your privacy.
How is this personal information collected?
Your information is collected from the practitioner who orders your test. If you provide information directly to us, this may be entered on your record as well. Information that you provide on the Compass trial consent form will also be entered on your record.
How may personal information be used?
Your personal information may be used for:
- Reporting the test ordered
- Charging for services (where applicable)
- The Compass Register to remind you or your practitioner if you are overdue for a Pap test or HPV test.
- Research to improve our knowledge, particularly on how to prevent cancer of the cervix. No research information identifies an individual person.
Future use of left-over LBC samples
Participation in the trial means that researchers will keep the remainder of your LBC sample. This may be used for future research to look at different HPV tests or to assist in monitoring the impact of the HPV vaccine. Approval from the Ethics Committee will be obtained prior to performing these tests. You will not have access to these test results, as the samples will be used for research and programme evaluation only and not to make a diagnosis of a medical condition.
Some residual samples may also be provided to Roche Molecular Systems for the purpose of validating new HPV testing instruments. Only de-identified data will be provided to Roche Molecular Systems and no information that would allow you to be identified will be provided to Roche Molecular Systems. You will not have access to these test results as the samples will be used for quality assurance and regulatory requirements for the development of new HPV testing methods. If you prefer that the remainder of your sample is not used for further research or for validating new HPV testing instruments then please indicate this by ticking the box on the consent form. The choice is yours and you can still participate in the Compass trial even if you don’t want your left-over sample used as described above.
Who is conducting and paying for the research
The trial is being carried out, and partially funded, by VCS Foundation in conjunction with the CCNSW. Some of the funding for the study has been provided by Roche Molecular Systems, which manufactures the HPV test used in the study. Roche Molecular Systems was not involved in the design of the study protocol, which is the responsibility of the Co-Principal Investigators, and Roche Molecular Diagnostics will have no role in the analysis of the data and no control over publication of the results of the trial.
This study has been approved by the Bellberry Ethics Committee and the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee. Research and Ethics committees ensure studies are performed to the highest scientific standard and in such a manner that the privacy, sensitivities and rights of each person participating in the research are protected. If you have a complaint or would like to speak to someone who is not involved in the trial, you can contact the Research Governance Officer, Bellberry Limited, Phone: 08 8361 3222, Email: firstname.lastname@example.org