We provide all necessary documents: patient informed consent to participate in the tumor profiling program; authorization and release of medical information forms; and laboratory test requisitions. We also provide a simple grant application for patients who need financial support.
A patient coordinator fills out most forms in collaboration with an oncology nurse. Physicians must sign laboratory requisitions. We coordinate the testing process with the pathology and testing labs. We currently collaborate with three CLIA-certified clinical labs to perform the testing: Caris Life Sciences, NeoGenomics Laboratories and Foundation Medicine.
Results are generally available within two weeks after the labs receive the tumor specimen. Once testing is completed, we send a summary report. Clearity offers assistance or consultation to interpret the report and can work with physicians and patients to incorporate this data into the decision-making process. We can also help identify appropriate clinical trials.
Tumor profiling is most likely to help women who:
- Have recently recurred or their cancer has progressed and they have had or will have another surgery or biopsy to remove tumor tissue. If a biopsy is not planned, part of the tumor blueprint can be performed on a sample from a previous surgery.
- Have been recently diagnosed with advanced (stage III or IV) cancer characterized as clear cell or mucinous histology or carcinosarcoma.
- Have been recently diagnosed with advanced (stage III or IV) cancer characterized as high grade serous and are considering entering a clinical trial for first-line or maintenance treatment.
Clearity’s research shows that results for the protein biomarkers from a recent specimen may be different from results from a primary tumor or older specimens. As a result, we do not generate the entire tumor profile (both gene and protein analysis) from archived tumor blocks older than one year. If a proximal tumor specimen is not available, we can arrange gene-based testing for a prior sample.
The test requires a standard formalin-fixed paraffin-embedded (FFPE) block. Some of the testing can also be performed on a cell pellet from peritoneal ascites fluid or a pleural effusion sample that is fixed in formalin and embedded in paraffin. The fluid samples should be processed within 30 minutes to be adequately preserved for this testing.
For biopsy specimens, a minimum of three core biopsies, aligned in an FFPE block, are required for analysis. It is preferable to have two blocks, each containing three core biopsies.
Clearity arranges for samples to be shipped from the pathology lab to our CLIA-certified testing facilities.
As a non-profit, Clearity’s services are free of charge. The costs associated with molecular testing can vary depending on the patient’s insurance. For patients who may need financial assistance to cover the cost of molecular testing, we offer a grant program to defray some or all of those costs.