Introduction

This lay summary is intended to provide a general overview of the Children's Oncology Group (COG) study # ALTE03N1. 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.

Study Number

ALTE03N1

Brief Title

COG ALTE03N1 – Key Adverse Events

Official Title

Key Adverse Events After Childhood Cancer

Trial Opening Date

Opened March 22, 2004

General Patient Eligibility

• Patients diagnosed with cancer at age 21 or younger
• Patients enrolled as "cases" have developed a late-occurring or long-term complication related to their cancer treatment that is being evaluated on this study
• Patients enrolled as "controls" have not developed a late-occurring or long-term complication, but have the same type of cancer, the same year of diagnosis, the same length of time since their cancer diagnosis, and the same race/ethnicity, as a patient who has been diagnosed with a late-occurring or long-term complication. Patients who are enrolled as "controls" will be identified by the Children's Oncology Group, and will then be contacted by the hospital where they received treatment and invited to participate in the study.
• Prior participation on a COG study is not required

General Background and Study Goal

Great progress has been made in treating children with cancer. With this success has come the awareness that childhood cancer treatment may lead to complications in some patients. These late-occurring or long-term complications include cardiac dysfunction (a damaged heart that is unable to circulate blood efficiently), avascular necrosis (poor blood supply to an area of the bone that causes permanent bone damage), stroke (blood flow to the brain is interrupted), or a second cancer. Certain patients may be at higher risk for developing these late-occurring complications, because of the type of treatment they received or because of inherited (genetic) factors; or the risk may be due to a combination of these reasons, or due to a cause that is not understood at this time.

The overall goal of this study is to identify patients who are more likely to develop late-occurring complications, so that in the future we can help, either by observing these patients more closely in order to find the complications early, or by preventing these complications from occurring at all.

Summary of the Treatment

If you decide to participate in this study:

• You will be asked to give a biological sample (about 2-3 teaspoons of blood or a saliva sample)
• You may be asked to complete a brief questionnaire about your family and health history
• Additional health information will be collected from your medical records
• Your participation in the study is expected to last 20 to 30 minutes

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
Professor, Division of Pediatric Hematology/Oncology
Director, Institute for Cancer Outcomes and Survivorship
University of Alabama at Birmingham/Children’s of Alabama

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS