COG Registry - Childhood Cancer Research Network (CCRN)

The COG has established a research network, known as the Childhood Cancer Research Network
(CCRN), for collecting information about children and young adults with cancer and other
conditions that are characterized by abnormal cell growth but are benign (not cancer). The
CCRN provides information that helps doctors and scientists better understand childhood
cancer.

Information Collection:

If you agree to take part in this registry study, the following information will be sent
from your hospital to the CCRN:

- Your name

- Your parent's/guardian's name(s), if you are under 18 years of age

- Your birth date

- Your postal/zip code

- The type and characteristics of your disease

- The date the disease was diagnosed

- The COG institution where you are being treated

- Your sex (whether you are male or female)

- Your race and ethnicity

Also, the diagnostic laboratory report that provides specific information about your tumor
will also be sent to the CCRN. This additional information is used to study how your
geographic location (where you live) affects your risk for different types of cancer.

Information Protection:

All information about you will be held in strict confidence. Your information will be marked
with a unique identification number instead of your name or other identifiable information.
This will help to lower the chance that your identifying information is released.

The only people who will be able to see identifying information about you are:

- staff workers directly involved in running the CCRN

- government workers who regulate or conduct oversight over the work of COG and/or the
CCRN

- researchers and their staff who direct and conduct CCRN-approved research studies

These people will all have signed agreements that they will not release any identifying
information about CCRN participants. At all times, the information about you will be treated
with a high level of confidentiality and will not be made available to anyone other than
those listed above, without your permission. Other researchers using your data will not be
able to link this data to you, unless you agree to allowing future contact.

If at any time you change your mind about having your name (and/or parent or guardian's
name) or any other information available in the CCRN, just contact M. D. Anderson at
713-745-0348. At that time, access to your name (and/or parent or guardian's name) and other
identifying information in the CCRN will be restricted. CCRN researchers will no longer
have access to your identity or any other information. You might still receive information
for studies conducted by researchers not related to the CCRN.

Reconsenting after age of majority:

If you are under 18 years of age now, your parent/guardian must sign this informed consent
before your name and any other information can be entered in CCRN.

When you reach the age of majority, (and if your parent or guardian agreed to allow your
contact information to be collected in CCRN), M.D Anderson researchers will contact you and
ask that you continue to participate in this study. If you agree to continue to
participate, you will sign this informed consent and your name and any other information
will remain in CCRN.

If you refuse to continue to participate, after the age of majority, access to your name and
other identifying information in the CCRN will be restricted, but your parent's/guardian's
name will remain in CCRN. Your parent/guardian might receive information for studies
performed by researchers not related to CCRN.

Certificate of Confidentiality:

The COG has received a Certificate of Confidentiality from the federal government, which
will help them to protect the privacy of their research participants. The Certificate
protects against the involuntary release of information about participants collected during
the course of their covered studies. The researchers involved in the studies cannot be
forced to disclose the identity or any information collected in the study in any legal
proceedings at the federal, state, or local level, regardless of whether they are criminal,
administrative, or legislative proceedings. However, the participants or the researcher may
choose to voluntarily disclose the protected information under certain circumstances. For
example, if the participants or their guardians request the release of information in
writing, the Certificate does not protect against that voluntary disclosure. Furthermore,
federal agencies may review the COG's records under limited circumstances, such as a DHHS
request for information for an audit or program evaluation or an FDA request under the Food,
Drug, and Cosmetics Act.

This is an investigational study.