Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients

Molecular Profiling/Deep Sequencing:

Molecular profiling is the classification of tissue based on the expression of certain genes
within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a
more detailed type of molecular profile that allows for a more focused analysis of individual
genes.

Biomarker Data:

A characteristic that is measured and evaluated as an indicator of normal biologic processes,
disease processes or pharmacologic responses to a therapeutic intervention.

Study Participation:

If you agree to take part in this study, information from your medical record will be
collected. The information that researchers will collect includes your medical history,
chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies
you may have had. Your responses to the therapies, your side effects, and the results of any
diagnostic tests performed during therapy will also be collected.

Researchers want to learn if they could have better predicted your response to therapy using
the information collected in this study and/or better predict side effects from your
treatment.

The data collected from your medical record will be stored in a password-protected database
at MD Anderson to be used in research related to this study for up to 10 years.

In addition, research studies on new biomarkers may be conducted on your previously banked
blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine,
saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.

Your name, medical record number, and any other personal identifiable information collected
from your medical record will be replaced with a code number. No identifying information will
be directly linked to the data collected from your medical record. Only the doctor who is in
charge of this study, and select members of their research staff, will have access to the
code numbers and be able to link any of the data back to you.

Use of Samples:

Before your banked tissue samples can be used for research, 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 tissue samples from this bank, must first be approved by the IRB.

Your tissue samples will be given a code number. No identifying information will be directly
linked to your samples. Only the researcher in charge of the bank will have access to the
code numbers and 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.

Length of Study:

Your participation in this study will be over after either the data, blood, tumor tissue
samples, and/or archived tumor samples are analyzed.

This is an investigational study.

Up to 2000 participants will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. All patients referred to the Clinical Center for Targeted Therapy are potentially
eligible for recruitment.

Exclusion Criteria: