What is the GO Study?

The main purpose of this study is to understand how genes might affect young people's chances of developing osteosarcoma. To do this we will compare the genes of young people with osteosarcoma to the genes of their parents. We will also look at how some lifestyle factors work with genes in osteosarcoma. Lastly, we will use medical records to see if young people with osteosarcoma grow differently than other young people.

How did you get my name?

Your child was contacted as a possible participant because he or she was diagnosed with osteosarcoma and has been registered with the Children's Cancer Research Network (CCRN) of the Children's Oncology Group.

What is involved in the GO Study?

Summary
If you participate, we will ask for three things: 1) we would collect some cheek cells from you and your child to look at your DNA, 2) we would ask you and your child to fill out surveys, and 3) we would collect medical records from your child's doctors and his or her birth certificate to see how he or she grew. We can use cheek cells from one of your other children (if you have one) if one parent cannot participate.

DNA collection
We would ask you and your child to donate a sample of cheek cells. Cheek cells will be obtained by having you swish a sample-size bottle of mouthwash inside of your mouth for about a minute. You then deposit it into a container. You may feel some tingling from the mouthwash but this shouldn't last too long. Samples can be returned to us using the pre-paid mailer. This part of the study takes about ten minutes. If we find out that your sample doesn't have enough DNA to be useful, we may call you for a replacement sample.

DNA and osteosarcoma
The cheek cells we collect will be used to study your and your child's DNA. DNA is the genetic material in a person's cells that makes them unique. There are thousands of genes in each cell which are made up of DNA. By studying the DNA, scientists can discover what genes might be involved in the development of osteosarcoma.

We know little about the factors we are studying, so the results will not provide information useful to you or your family. This information is for research purposes only and you will not be informed of your individual DNA tests. However, if you wish, we can inform you of the overall findings from the study once the study has been completed.

DNA use and storage
Your and your child's DNA sample will be used for research by Logan G. Spector, Ph.D. and his associates for the purposes of learning more about osteosarcoma. We have some genes that we know right now that we're going to study, but there might be other ones that we only think to study in the future, so we'd like to keep your DNA sample for a long time. In some cases, your and your child's DNA samples could be sent to other research groups for analysis. You would not be notified, but any samples we send to another researcher would be identified only with a number and will not be able to be traced back to you. You or your child will not be identified in any publication or reports from this study.

We will contact your child when he or she turns 18 to see if we can continue storing his or her DNA sample. You can request that your and your child's DNA sample be destroyed at any time up until 2014 by contacting Dr. Spector. After 2014 we will remove your name and your child's name from our files and would not be able to tell which DNA sample is yours.

Survey
We will ask you to complete a questionnaire about jobs you've had, places you've lived, your family's medical histories, and your child's growth, development, and health. There is also space on the survey for you to write down the names of all the doctors your child has seen for routine care so we can get medical records from them. We would ask that your child fill out a brief survey covering diet, exercise habits, and the time spent in the sun in the year before he or she was diagnosed with osteosarcoma. If there are unclear answers on the survey we may call you back to clarify.

Medical records
We would ask that you grant us access to your child's medical records related to growth, including your child's birth certificate. If your child has been diagnosed with a genetic condition we would also ask for records related to the condition. You will need to sign separate authorization forms for release of your child's medical records and birth certificate.

Who is eligible for this study?

Families are eligible for this study if:

1. a child is registered with the Children's Oncology Group.
2. the child was diagnosed with osteosarcoma during the recruitment period.
3. the child was diagnosed with osteosarcoma at less than 20 years of age.
4. at least one biological parent is alive and willing to participate.
5. the parents and child filling out the questionnaires understand English or Spanish.

Parents of children who were diagnosed with osteosarcoma, but are deceased, may be eligible to participate.

How many people will participate in the study?

The study will open on July 1, 2007 and enrollment will continue through 2010. It is expected that 500 children with osteosarcoma along with their parents will participate in this study by completion.

What are the benefits of participating in the GO Study?

There will be no direct benefit to you or your family. This research may help us understand why young people get osteosarcoma.

When will the study results be available?

We expect to report the results of this study within the next five years. No individual would ever be identified; all data are coded by identification numbers and only group results are presented.

Can I receive the study results?

Absolutely. Group results will be available a few years after the study is completed. When a member of the study staff calls, let her know that you would like to receive the study results.

What if I have questions?

If you have any questions you can reach study staff at 612-624-3912.