What is tumor molecular profiling?

Molecular profiling refers to testing that is conducted in order to understand how tumor cells are functioning at the molecular level. The tests examine proteins and genetic material (DNA) that may indicate whether the tumor is likely to be sensitive or resistant to certain approved cancer drugs or drugs that are being tested in clinical trials.

What is a Tumor Blueprint?

The Clearity Foundation’s Tumor Blueprint is created for you based on your tumor’s molecular profile. Once our laboratory partners have sent your test results, Clearity’s team of experts uses that information to create an interpretive report based on both clinical research evidence and patient data from the Clearity Database. This report provides a summary of commercially available agents and clinical trial agents that are associated with potential clinical benefit, as well as details of the lab results and information about how your data compare to other patient results in our Database.

How will my doctor use the information in my Tumor Blueprint?

Your physician can use the summary of therapy agents detailed in your tumor blueprint based on your molecular profile, along with your medical history, the stage of your cancer, how much time has passed between initial therapy and cancer recurrence, and other factors, to determine which therapy option to prioritize. You and your physician should also discuss any clinical trials for which you may be eligible.

Who should be tested?

Tumor profiling is most likely to be beneficial if one of the following statements describes your situation:

• “I am having a recurrence since my first diagnosis and my doctor has planned another surgery or a biopsy to remove tumor tissue.”

• “I have had a recurrence since my first diagnosis and another surgery or biopsy was performed to remove tumor tissue during the last year.”

• “I have advanced stage ovarian cancer that is clear cell or mucinous histology or carcinosarcoma”

What type of sample is needed?

All panels require a surgically-obtained sample of your tumor tissue or tumor cells obtained from fluid that accumulates in your lungs or abdominal cavity. All of the tests in our panel can be performed on archived tumor samples that were taken within the last 12 months.

Why do you only test tumor specimens that are obtained within the last year?

Studies have shown that tumors evolve over time, particularly in response to chemotherapy treatment. Recurrent tumors are often different from the original tumor. So, the Clearity Tumor Blueprint is generated using a sample that is removed as recently as possible so that it matches the cancer that is to be treated as closely as possible.

I’ve already had my surgery. Is it too late to get my Tumor Blueprint?

No, as long as your surgery has occurred within the past 12 months. Our testing panel is performed on archived tumor samples.

How does my sample get to the laboratories for testing?

The Clearity Foundation will coordinate getting your sample to our clinical lab partners once we have all the necessary paperwork from you and your doctor.

What if I don’t live in the U.S.? Can I still get my Tumor Blueprint?

Contact the Clearity Foundation at +1 (858) 657-0282 or patientsupport@clearityfoundation.org for details and special arrangements.

Once we have the test results, what’s next?

If your cancer continues to progress, the Clearity Foundation will help you and your doctor with treatment options, including facilitating choices for clinical trials. If your tests show that your cancer is likely to be sensitive to a particular drug we will work together with your doctor to find a protocol for your future treatment.

Why aren’t the drug companies doing this themselves? How does the Clearity Foundation help?

Drug companies make choices about their testing because the drug development process is so rigorous and a high volume of patients must be tested prior to the drug’s approval. Because the FDA requires statistical significance in these trials (a certain number of patients enrolled), drug companies develop for indications first where there is a high incidence rate, such as breast cancer (178,000 new diagnoses per year) rather than diseases such as ovarian cancer (22,000 new diagnoses per year). Signing up to have your blueprint determined will help encourage drug companies to conduct more clinical trials in ovarian cancer. Understanding the profiling data across the ovarian cancer population may help to direct and encourage the development of new treatments.

Who performs the biomarker testing?

The Clearity Foundation has established relationships with CLIA-certified clinical labs to perform the testing. Currently, our partners include Caris Life Sciences, NeoGenomics Laboratories, Inc., and Foundation Medicine, Inc.

How long does it take to get my Tumor Blueprint?

Once our clinical laboratory partners receive the sample, it typically takes 2-3 weeks to get the results from the testing. Your Tumor Blueprint will be sent to you approximately 2 days after we receive the laboratory results.

How much does it cost to get a Tumor Blueprint?

As a non-profit organization, the Clearity Foundation provides its patient support services free of charge. These services include test coordination, reporting and interpretation of test results, and identification of clinical trials for which you may be eligible.

The cost of the biomarker and genomic testing can vary depending on your insurance. We are committed to helping women with ovarian cancer make more informed treatment decisions regardless of their ability to pay. Our grant process exists as a way of identifying patients that need financial assistance to cover the cost of biomarker and genomic testing. Please do not hesitate to fill out our Financial Assistance Form.

How can I support Clearity’s mission?

The Clearity Foundation relies on charitable donations to support our Tumor Blueprint services, as well as our patient and physician educational programs. We encourage those interested in supporting our mission to make a donation, volunteer, or host or participate in a fundraising event.