CCRN - Considering Registration

After your child’s diagnosis at a COG institution, you and your child will be approached by staff to consider registration in the CCRN. You will be given materials to look over that describe the CCRN and address questions you may have about participating in it. Your healthcare team is available to answer any questions that you may have. You will also be given a consent form that explains different ways that you and your child can participate in the CCRN. Full participation in the CCRN is voluntary.

There are two (2) parts of registration to consider:

You will be asked if you are willing to provide permission to have the following information sent from your child’s hospital to the CCRN:

• Child’s name
• The name of the person giving consent
• Child’s birth date
• Whether your child is male or female
• The race and ethnicity of the child
• Type and characteristics of the child’s cancer
• Date the cancer was diagnosed
• Children’s Oncology Group institution where the child is being treated
• Child’s medical record number or hospital ID

If your child is being treated on a COG protocol, information regarding your child’s tumor status will be updated annually as part of the treatment follow-up. Also, the diagnostic laboratory report that provides specific information about your child’s cancer will also be provided to the CCRN, if you agree to participate.

You will be asked if you are willing to be contacted in the future to consider participating in CCRN research studies that may involve you and/or your child.

If you agree to be contacted in the future, your home address and telephone number will be registered with the CCRN. You will only be contacted by researchers whose studies have undergone scientific review and were found to be very important. You are not agreeing to be in any studies right now, you are just to being asked if you would like to hear about more studies in the future. It is possible that you will never be contacted.

When you have made your decision about you and your child’s participation in the CCRN, you will be asked to sign a consent form. If your child is age 18 or older, he or she will also be asked to review and sign a consent form to verify that they are willing to participate in the CCRN. If your child is between the ages of 8 and 17, he or she will be asked to sign an assent form to show that they agree to participation in the CCRN.

CCRN - Changes to Your Approval Status

If at any time you or your child chooses to change or remove information shared in the CCRN, you may call the CCRN staff, at (626) 241-1760, and the information in the CCRN will be changed in a timely manner.

When your child reaches the age of 18, he or she will be contacted and asked to continue their participation in the CCRN. At the age of 18, information contained in the CCRN will be made unavailable to researchers if

• We cannot make contact with your child to obtain consent or,
• Your child refuses to continue to participate in the CCRN,

Please note: If your child does not consent to be a part of the CCRN at age 18, your consent to be contacted, as a parent or guardian, will still be honored.

CCRN - Refusing Consent

If you are not interested in having you and your child included in the CCRN, you may refuse consent. If you refuse, some minimal information about your child will still be entered into the CCRN. However, no identifying information will be entered.

The minimal information that can be entered in the CCRN database without your approval includes:

• Your child’s diagnosis
• The year of your child’s diagnosis
• Your child’s year of birth
• The first 3 numbers of your postal zip code (if the area's population is greater than 20,000 people)

Entering minimal information is mandatory for patients being treated at COG participating sites. This information is stored on all patients to:

• Avoid duplicate registration of individuals in the CCRN
• Study relationships between geographic location and risk of cancer

CCRN - Risks of Participation

One risk to participating in the CCRN is the release of personal health information, including health records. The CCRN will protect your child’s records so that all information is kept private. The chance of this information being given to someone outside of the CCRN staff and approved researchers is very small.

Another possible risk is that being contacted for future studies may bring up painful feelings or memories about your child’s treatment. It is important to remember that if you are contacted to participate in a study, you are under no obligation to participate Participation in all CCRN studies is entirely voluntary.

The Childhood Cancer Research Network Pilot Study: Testing the CCRN

Between March 2002 and December 2006, the Childhood Cancer Research Network (CCRN) registry was tested at 23 COG institutions. As of December 31, 2006, the families of 2,224 patients were asked to consider participation in the CCRN.

This pie chart shows the decisions of these 2,224 families. Their decisions are broken down into 3 groups:

• 2,127 families (96%) Agreed to be in the CCRN registry and agreed to be contacted by COG in the future.
• 70 families (3%) Agreed to enter personal identifiers in the CCRN registry but did not agree to be contacted by COG in the future.
• 27 families (1%) Refused to register personal identifiers in the CCRN registry and did not agree to be contacted by COG in the future.

The pilot study was a success and all COG institutions began to use the CCRN registry on January 10, 2007.

What is the Children's Cancer Research Network?

First piloted in 2001, the Children's Cancer Research Network (CCRN) is a North American pediatric cancer research registry that has been established by the Children’s Oncology Group for all COG member institutions in the United States and Canada.

Through an informed consent process, the initiative enables researchers to follow the health of patients into adulthood using a unique, confidential, non-transferable CCRN identifier. In this way, parents and children contribute to science by adding to the overall knowledge of the causes of cancer, and, through the study of late effects of treatments, help researchers develop improved therapies that have will fewer side effects. COG will also be able to document the contributions and accomplishments of cancer survivors as they become productive adults as well as cancer survivors. COG will be able to evaluate new biologic and epidemiologic information on this large cohort of patients.

How Does CCRN Work?

At the time of initial diagnosis, parents (and children old enough to understand) have three options for participation:

• Not to participate in the CCRN;
• To register with CCRN, but to decline future contact to participate in future research;
• To register with CCRN and agree to future contact with researchers participating in COG-sanctioned nonclinical studies.

The level of participation can be changed at any time, at the request of parents (or the patient, if over age of majority). All patients will be re-consented at the age of majority.

Why is the CCRN Important?

Thanks to more than 50 years of research conducted by the Children’s Oncology Group and its legacy groups, there are more than a quarter of a million childhood cancer survivors now living in the United States. Cure rates for childhood cancer have risen from less than 10 percent in the 1950s to nearly 80 percent today. Survivors of cancer often face long-term side effects from their treatment and this registry will allow the COG to continue to follow patients into adulthood.

By following this growing population of survivors, and conducting future research, the Children’s Oncology Group will be able to confirm that new therapies being developed in the laboratory are leading to fewer side effects later in life. This has always been one of the primary goals of the Children’s Oncology Group; not only to “cure” but to “cure better.”

This initiative is being led by Julie Ross, Ph.D, Professor and Director of the University of Minnesota’s Division of Pediatric Epidemiology and Clinical Research. Dr. Ross serves as Principal Investigator of the CCRN and Chair of the Epidemiology Committee of the Children’s Oncology Group.

Status Update - 2/27/2011

19,586 patients have enrolled. Of those, 18,195 (93 %) have also initially agreed to be contacted about future research.