Introduction

This lay summary is intended to provide a general overview of the Children's Oncology Group (COG) study # ALTE05N1. It will provide information about the children who are eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

It is important to understand that participating in a long-term follow-up study is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the healthcare team in any way. You can find additional information about participation in non-therapeutic studies at www.childrensoncologygroup.org. Always discuss any questions that you may have with your healthcare team.

Brief Title

COG ALTE05N1 - Umbrella Long-Term Follow-Up Protocol

Official Title

COG Umbrella Long-Term Follow-Up Protocol: A Group Wide Non-Therapeutic Study

Study Opening Date

Opened May 19, 2008

General Patient Eligibility

• Patients treated on a COG clinical trial for their primary cancer
• Patients must be enrolled within 180 days of completing therapy
• Individuals enrolled on one of the COG studies listed in the protocol (Appendix 1)
• Participants must live in the United States

Please consult your doctor to determine whether you may participate in this study.

General Background and Study Goal

Great progress has been made in treating children with cancer. With this success comes the need to monitor patients' health status and quality of life years after treatment ends. The COG Long-Term Follow-Up Center was established to improve the collection of follow-up information on survivors of childhood cancer.

The overall goal of this study is to keep in contact with participants of COG clinical trials so that up-to-date information is available on these participants as they get older. This information includes the participant's current contact and health status information, as well as the contact information of the participants' parents and another family member or close friend. While social security and driver's license numbers are requested, this information is optional.

Summary of the Treatment

• The Long-Term Follow-up Center will contact you regularly to update your contact and health status information.
• You may be invited to participate in long-term follow-up research studies.

Risks and Side Effects

All risks and side effects will be explained by your study team during the consent process. They can answer any questions that you may have about giving permission to be in the study. The study consent form has more details about possible risks and side effects of this study.

Contact Information

Your oncologist is the best source for further information. Physicians with eligible patients should refer questions to the principal investigator:

Principal Investigator

Smita Bhatia, MD, MPH
University of Alabama at Birmingham/Children's of Alabama

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS