Why are we doing this study?
There are more than 200 types of cancer. We hope this study will help doctors decide what type, how much risk, and the best treatment for any specific cancer.
Body tissues are made up of cells. Cells contain DNA, which is the genetic material that carries the instructions for the body’s development and function. Cancer can result from changes in a person’s genetic material that causes cells to divide in an uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and doctors know some of the genetic changes that can cause cancer, but they do not know all of them. Therefore, we would like to study the genetic material from the participating patient’s blood, tissue and body fluids. We will perform this same process with up to hundreds of other pediatric patients who are taking part in this study. By combining genetic information with clinical data, it may be possible to identify the genetic changes that are associated with an individual’s particular type of cancer and to identify trends in what cancers respond to various treatments. With such knowledge, future treatments potentially could become customized to a patient’s unique genetic make-up.
Who can participate in this study?
We are looking for patients who are 18 years old and younger who have been diagnosed with cancer or may be at risk for cancer. There are some other requirements you must meet to protect your safety. If you are interested in taking part in this study, the study team will discuss this with you.
What will happen during this study?
The patient’s medical records will be reviewed to study what the patient and other pediatric patients at risk for cancer all have in common. A number of tests will be performed throughout the study. Many of these are part of regular cancer care, but some may be just for research. These include:
- Storage of excess tissue removed at the time of the patient’s surgery
- Collection of extra blood sample at regular clinical care blood draws
- Collection of tumor samples at the time of the patient’s diagnostic biopsy
- Collection of tissue samples from previous procedure
- Collection of other body fluid or tissue samples
We will attempt to stay in touch with the patient and review his/her medical records yearly for as long as the study remains in progress, which we hope will be for the patient’s lifetime to assess long-term effects of the cancer and/or treatments given.
Is this risky or painful?
We believe that there is very little chance that bad things will happen as a result of being in this study. Many of the samples requested by the study will have already been collected as part of the patient’s regular cancer care. Other samples (for example, blood and bone marrow) will be collected at the same time as clinical care samples to avoid extra procedures; therefore, there is very little to no added risk in obtaining the extra sample for research.
The procedures used to obtain the biological samples carry their own risks depending on which type of sample is collected. Each procedure, along with its risks, will be reviewed at the beginning of the study and again prior to beginning each procedure.
There is also a risk of loss of privacy since information will be collected from participants’ health records.
Many steps are in place at to prevent this. Additionally, there are laws in place at the federal level and in many states that protect genetic information.
What are the benefits?
There may be no direct benefit to the patient if he/she takes part in this study. We hope the information learned from this study will benefit others with cancer in the future.
Where can I get more information?