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Can I volunteer to participate in the PRESEPT Study?
Reflecting a true colorectal cancer screening population in the PRESEPT Study is of utmost importance to the success of the study. To achieve this, all clinical sites have stringent criteria to apply in the enrollment of subjects into the study. For this reason, please understand that participation in the PRESEPT Study is by invitation through a gastroenterologist participating in the PRESEPT Study only and you cannot volunteer to participate in the study. Thank you for your understanding.
How do I know that I participate in the PRESEPT Study?
You will be approached by your doctor or a study nurse who will explain the puspose and the details of the study to you. You will only participate if you give your wirtten consent. The participation is completely voluntary.
Does PRESEPT pay for my colonoscopy?
No, only patients previously referred for a regular screening colonoscopy may be subsequently enrolled in the PRESEPT Study. The colonoscopy is either covered by your health insurer or yourself as it would be if you did not participate in the study.
Is there any risk involved in participating in PRESEPT?
The only risks associated with participating in the PRESEPT Study are the risks of a routine blood draw at the gastroenterology practice, hospital or clinic, or the potential loss of confidentiality of protected health information. All professionals involved in the execution of the PRESEPT Study have the necessary training to minimize these risks.
What do I have to do if I participate in the PRESEPT Study?
After the doctor or the study nurse explains the study and the procedure to you, you have to give your consent in writing on a form provided by the clinical site. Then you have to answer a few simple questions regarding your medical history. Your answers are noted in a special form which records your case number, but not your name on it. An extra blood draw will be arranged prior to the scheduled colnsocopy. That’s it. All further forms will be processed by the doctor or the study nurse.
What happens to my personal and clinical data when I participate in PRESEPT?
Your medical history and clinical data is saved with a case number but not your name. Only your doctor has the link between your name and the case number. However, neither you or your doctor will ever know the results of the PRESEPT test.
Am I informed on the results of my mSEPT9 test if I participate in the PRESEPT Study?
No. The results of the mSEPT9 blood test are filed with your case number but not your name and cannot be traced back to you by the sponsor of PRESEPT. Also, the samples will only be analyzed at the very end of the study. In the mean time your doctor has the results of your colonoscopy and will take all necessary decisions based on his findings during the colonoscopy.
How do I learn about the results of the PRESEPT Study?
Epigenomics, the sponsor of the PRESEPT Study will publish regular updates on the study progress and the results of any data analysis. You will find the press releases in the newsroom on the PRESEPT website at www.presept.net.
Can I ask my doctor to get tested for the mSEPT9 biomarker?
The mSEPT9 test is still in development by Epigenomics and its partners. The PRESEPT Study is part of this development. Currently the mSEPT9 biomarker performance has not been evaluated by any regulatory authority and the test is not yet approved or offered for diagnostic testing.
When will the mSEPT9 test become available?
Epigenomics expects mSEPT9 testing services offered by reference laboratories to become available in the U.S. in late 2009 or early 2010. In Europe first mSEPT9 IVD tests are expected to be launched in late 2009.
Does the mSEPT9 test replace colonoscopy?
No, it is the current belief of Epigenomics that the mSEPT9 test should provide a convenient alternative to other non-invasive screening tests for colorectal cancer such as FOBT or FIT.
What are the likely consequences when I test positive for mSEPT9?
If a patient tests positive for the mSEPT9 biomarker, the likely follow-up is a colonoscopy for definitive diagnosis oft the cancer. Only then will the doctor decide on whether there is cancer and how to treat it.
If I test positive for mSEPT9, does this mean I have colorectal cancer?
Not necessarily. Although a positive test result means that you have a high risk of having colorectal cancer, as with any other diagnostic procedure, tests can give false positive results are possible. That is why your doctor will recommend to follow up with a colonoscopy for definitive diagnosis. |
