Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program

Summary: The main goal of this study is to perform standardized testing of tumor tissue to learn which genes are mutated (have changed) to provide personalized cancer therapy options to patients at MD Anderson. Your doctor may be able to use testing information on your tumor to identify clinical trials that may be most relevant to you.
  Another goal of this laboratory research study is to learn how often different genes mutate in patients with different cancers. Researchers will also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.
  Researchers also hope to better understand how mutations in cancer-related genes may affect a patient's response to different therapies. Researchers can use this information to select specific therapies for future patients that are more likely to be effective.

Detailed description: If you agree to take part in this study, information about your disease and your previous and future treatments and outcomes will be recorded from your medical records. A sample of your tumor tissue that was already collected and stored at MD Anderson or another institution will be collected.
  If your tumor tissue is stored at another institution, a company called eHealth Global that specializes in picking up and delivering this kind of tissue, may be used to collect and deliver your samples to MD Anderson. If eHealth Global is used, they may have access to certain identifiable health information, which will include the accession number of your tissue sample, your demographic information (to know where to pick up the sample), and your Medical Record Number (used to label the sample so that the laboratory knows that it is for your tests). eHealth Global will not keep this information and it will only be used to move your samples from the outside institution to MD Anderson.
  Your medical record information will be entered into a password-protected database that can only be accessed by authorized members of the research staff and your treating physician at MD Anderson.
  The tissue sample will be tested to look for mutations in cancer-related genes and for protein testing. Any leftover DNA will be stored in a research bank at MD Anderson for future research related to this study.
  Before your samples can be used for research outside of this study, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your samples from this bank, must first be approved by the IRB.
  Your samples will be given a code number. Researchers in the laboratory will not have identifying information directly linked to your samples. However, the researchers in charge of this study and their team members, as well as your oncologist will be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.
  Some of your sample material may be sent to institutions outside of MD Anderson for advanced testing.
  Some of your samples may be sent to outside institutions or companies (such as Guardant Health Inc.) for clinical laboratory improvements amendments (CLIA)-verified advanced testing. A CLIA-certified lab has to meet certain standards for all lab testing to ensure accuracy, reliability, and timeliness of patient test results regardless of where the test is performed. Your name and a sample identifier, along with information about your sample and disease that are necessary to complete the testing will be provided along with your sample. The information from the CLIA-certified tests done at outside companies or institutions will become part of your medical record.
  If your sample is sent to outside institutions for standard research testing only, no identifying information about you will be included with the sample. Results from standard research tests from outside companies or institutions will not be included in your medical record and you will not receive information about the results of these tests.
  Length of Study:
  Your active participation will be over after you sign this consent form and your tissue and blood samples have been collected. You medical records may continue to be reviewed for up to 20 years.
  This is an investigational study.
  Up to 8,000 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility: Inclusion Criteria:
  1. Patients must have histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer. Patients with benign tumors may also be consented at the discretion of the attending physician if molecular profiling is felt to have potential clinical implications.
  2. Patients must have the ability to understand and the willingness to sign a written informed consent document.
  3. Patients may be consented without confirming the amount and quality of archival diagnostic or residual tissue available. However, research testing will only be performed on patients who have sufficient archived diagnostic tissue or residual tissue banked in one of the authorized tissue banks at MD Anderson available to proceed with testing. The extent of testing may be modified based on amount of tissue available. If any new tissue acquisition including a biopsy and/or surgical resection etc. is being ordered for clinical care or another research study, or an operation is being performed testing can be ordered on that sample.
  4. cfDNA Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will be performed with the CLIA-certified Guardant360 panel (or equivalent) for select patients. This particular cohort of research collaboration will be supported by Guardant Health, Inc. at no charge to MD Anderson. Patients who are being considered for enrollment into clinical trials in the next 2 lines of therapy may be enrolled.
  Exclusion Criteria:

Relevance to patient case: not relevant