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Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments

Virginia Piper Cancer Center (Scottsdale, Arizona) is excited about a new trial they have just started which uses Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments. It would be for patients that seem to be running out of options.  (There are currently 3 trial locations: AZ, TX, and SC:  see below.)

If you agree to take part in this study, you must be willing and able to attend all appointments at the trial center and take your treatments as instructed by the trial Doctor.  You will not be paid for your participation in this study.

The purpose of the study is to determine if your tumor has any targets (specific proteins) that may respond to a treatment that has been chosen using a method called molecular profiling.  Molecularprofiling is a way to
analyze your tumor looking at DNA, RNA and proteins to determine possible therapeutic targets specific for your tumor, and thus potentially enabling the selection of a more specific therapy for your cancer.  After a molecular profiling is performed on your tumor, by a specialty certified lab (CLIA certified) called Molecular Profiling Institute (MPI) a specific treatment will be selected by an oncology doctor working with the sponsor.  Using specific guidelines set in place as a part of the study, your oncology doctor will be told the drug or drugs, which are most likely to be of help to you.

There will be no investigational drugs used as part of this study.  Your doctor will treat you using drugs that are already approved by the FDA and commercially available to treat cancer, although not your specific type of cancer.

The experimental aspects of this study are the testing of your tumor biopsy for targets and the method used to select your treatment.

They determine how long your tumor stays stable or shrinks compared to how long your tumor stayed stable or shrank on the treatment you had just received before entry in this study.

They will be taking approximately 92 patients in this trial.

In order to participate in this study you will be asked to give more tumor cells by having another biopsy or surgical procedure to obtain a portion of your tumor before starting treatment.  You will be asked to sign a separate consent form.  There are risks with this and the doctor will explain them.

A portion of your tumor will be molecularly profiled using several types of laboratory tests that will isolate DNA, RNA and proteins from your tumor.  DNA and RNA are the genetic material found in each of the cells throughout your body.  Your DNA contains "genes" which predict things like physical characteristics and may also be a factor in whether you develop or are at risk for developing certain illnesses or disorders.  Proteins are found throughout your body and are essential to the structure and function of all living cells.   The DNA, RNA and proteins that will be isolated from your tumor will be used to determine if your cancer has any targets that may respond to an existing treatment.

A portion of your blood will be used to isolate proteins circulating in your blood.  These proteins will be analyzed to determine if they may be able to predict your response to your cancer treatment.  Your tissue and blood will be used only for research and will not be sold.  There are no plans to pay money if profits should arise from working samples.  The sponsor of the study, Scottsdale Clinical Research Inst intends to own anything that results from the research.

Genetic testing sometimes reveals a previously unrecognized or unexpected genetic condition or problem.  This condition may or may not affect your health.  If possible and you give permission to, such findings will be
reported to you through your healthcare provider, who will explain the potential meaning of the finding.  As a result of this knowledge, you and your family may experience stress, anxiety, or changes in your current way
of life.

The cost of the tumor biopsy or surgical procedure performed to obtain a portion of your tumor, and the cost of the medications to treat your tumor based on the lab tests performed as part of this study will NOT be covered by the study sponsor.  The drugs that will be used in this study are already approved by the FDA and commercially available to treat cancer, although not necessarily your specific type of cancer.  Your insurance will be billed for the cost of the tumor biopsy, or the surgical procedure performed to obtain a portion of your tumor, the cost of the medication to treat your cancer and any lab or other tests such as CT's.  You may be responsible for any charges not covered by your insurance company.  You will not be paid for your participation in this study.

ABOVE are just some EXCERPTS summarized by Kathy Flom from trial documents;  Kathy wanted to pass this information along to friends here on GSI.  Those who are interested should contact Virginia Piper o an alternate location (see below) and read thoroughly the entire information packets and/or consent forms prior to signing up for the trial.

Nurse Trial Coordinator at Virginia Piper Cancer Center, Scottsdale, Arizona is:
Patti Hopper, RN, OCN 
480-323-1350.
Her email is:
phopper@shc.org

In addition to Virginia Piper  the Molecular Profiling Clinical Trial
will also be offered at:

Tyler Cancer Center
310 E Houston Street
Suite 100
Tyler, Texas
Phone 303-573-3800
Dr. Richards

Cancer Center of Carolinas
300 West  Faris Road
3rd Floor CTC/CRU
Greenville, SC
Phone 864-673-3966
Lesa Johnson RN -Research Nurse
864-673-3967
Dr. Stephenson

Here are some links describing more about the bacckground for this trial:

Molecular Profiling was started in collaboration with Scottsdale Healthcare
in laboratories at the Virginia G. Piper Cancer Center in Scottsdale.

Scottsdale Healthcare and the Translational Genomics Research Institute (TGen) have formed a strategic alliance in which Scottsdale Healthcare will become a primary clinical research site for TGen.

Molecular Profiling Institute is a specialty reference laboratory that utilizes discoveries from the Human Genome Project to analyze cancers from individual patients.



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