Introduction

This lay summary is intended to provide a general overview of the Children’s Oncology Group (COG) study ALTE15N2. It will provide information about the children, adolescents, and young adult 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 health care team.

Study Number

ACNS1422

Brief Title

COG ALTE15N2 – LEAHRN

Official Title

Late Effects After High-Risk Neuroblastoma

Trial Opening Date

Opened June 5, 2017

General Patient Eligibility

• Patients who are at least 5 years old and less than 50 years old
• Patients diagnosed with high risk neuroblastoma after January 1, 2000
• Patients enrolled on the biology study at the time of diagnosis (ANBL00B1)
• Patients who are at least 5 years from the date of their diagnosis
• Patients who have not received any treatment for their neuroblastoma for at least 2 years

General Background and Study Goal

Incredible progress has been made in treating neuroblastoma. With this success has come the awareness that childhood cancer treatment may lead to complications in some patients. The goal of this study is to learn how the treatment that children received for high risk neuroblastoma affects their health over time. These side effects include effects on organs, second cancers, changes in how the patient grows and/or develops during puberty, and how they process information and interact with others. This study will look at patient characteristics along with clinical and treatment risk factors that may lead to these late complications. The study will look at the impact of newer therapies such as immunotherapy in relation to these late effects.

Collecting this information will lead to the development of an identified group of high-risk neuroblastoma survivors and allow for storage of blood (optional) from these survivors treated with many types of therapies. The identified group will be a resource for potential future studies to help us understand how these therapies impacted the patient and family.

Summary of the Treatment

If you decide to participate in this study:

• You will have clinical testing, including blood and urine samples, to determine your current health status.
• You will be asked to have heart, lung, hearing tests, and X-rays done if you have not had them done within the last 12 months.
• You will complete paper questionnaires about your everyday thinking and learning and about your background, medical history, and family history. A parent/guardian may also fill these questionnaires out. These will take around 45 minutes to an hour to complete.
• You will be asked if you would like to give a blood sample (about 1- 1 1/2 tablespoons of blood) for future “banking or storage” for research. This is optional.
• Some health information will be collected from your medical records
• Your participation in the study is expected to last no more than 12 weeks depending on what testing needs to be completed.

Risks and Side Effects

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

Principal Investigators
Tara Henderson, MD, MPH
University of Chicago Comprehensive Cancer Institute

Lisa Diller, MD
Dana-Farber Cancer Institute

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS