What is the HOPE Study?

The HOPE study was designed to try to find things that might cause hepatoblastoma in infants and children. Hepatoblastoma is very rare; only about 1 case occurs in every 1 million children under the age of 15. Although the number of cases is low, the rate of hepatoblastoma is increasing about 3% per year. It is not known why hepatoblastoma happens or why the rate is increasing. It could be due to certain exposures, genetics, a combination of the two, or by chance. Recent studies have shown an increase risk of hepatoblastoma among those children born at low birth weight. One factor this study is examining is the role of treatment for premature infants in the development of hepatoblastoma.

This is a national study that is being conducted by researchers at the University of Minnesota through a grant funded by the National Cancer Institute. It is an epidemiology study. Typically, epidemiology studies rely on questionnaires to ask people about personal habits, medical history, and other information. Nowadays, epidemiology studies often also involve DNA. The researchers then look for differences between groups of people who develop the disease and those who do not.

This is the largest study of hepatoblastoma that has ever been conducted. The three key questions that researchers hope to answer through this study are:

1. What are the most important risk factors for hepatoblastoma?
2. What are the genetic differences between children who develop hepatoblastoma and the children who do not?
3. How are environmental and genetic factors related in the development of hepatoblastoma?

What do we hope to gain from this study?

We hope to learn more about the factors that may contribute to the development of hepatoblastoma. This is done by asking mothers with children who have been diagnosed with hepatoblastoma about their medical history and about various items they have been exposed to and comparing the information to that collected from mothers whose children do not have hepatoblastoma. The doctors and researchers hope that through very carefully determined questions they might find a common thread among those who have developed hepatoblastoma (this research is called epidemiology).

This process is a very common way to start an investigation into the causes of cancer. If we find a common thread, then laboratory scientists will investigate this further to see if there is a biological reason why the particular exposure might be associated with cancer. The results of the study may help us determine whether a reduction or change in environmental factors could contribute to a decrease in the occurrence of hepatoblastoma. All information collected will be kept strictly confidential. Participation in this study is entirely voluntary.

How did you get my name?

You were selected as a possible participant in this study because your child was diagnosed with hepatoblastoma at an institution affiliated with the Children's Oncology Group.

Who is eligible for this study?

In order to participate in this study your child must:

1. be registered with the United States Children's Oncology Group and diagnosed with hepatoblastoma between January 1, 2000 and December 31, 2008.
2. have been diagnosed with hepatoblastoma between ages of 0-6 years.
3. have been born in the United States
4. have a birth mother available for interview that speaks English or Spanish

Mothers of infants/children who were diagnosed with hepatoblastoma, but are deceased, are eligible to participate.

How many people will be involved with the study?

The study is currently open and enrollment will continue through 2008. It is expected that mothers of 600 infants with hepatoblastoma and mothers of 720 children without hepatoblastoma (who were born around the same time as the infants with hepatoblastoma) will participate in this study by completion.

What will I be asked to do?

Unlike therapeutic studies, patients will not be asked to take any medications or use any medical devices. Instead, mothers are asked to participate in a one-time telephone interview. The interview will take about 45-60 minutes. We will schedule the interview only at a time that is convenient for you. You just let the interviewer know what time works best for you. Some mothers prefer to break up the interview over a few telephone appointments. Carefully determined interview questions will ask for information related to medical history, family health history, personal habits such as smoking, reproductive history, jobs and events surrounding the child's birth. It is important to emphasize that when the study started, the researchers did not know if any of these things had any effect on children getting hepatoblastoma. Only by asking questions such as these can we learn whether any of these factors are important in the development of hepatoblastoma.

The other part of this study involves an optional collection of cheek cells for DNA analysis from yourself and your child. If you wish, you can choose not to take part in this part of the study; it is entirely up to you. Finally, if your child weighed less than five pounds, eight ounces, we will ask you to authorize the release of medical records relating any treatment your child may have received in the first few months of life.

Why do you want DNA samples?

The purpose of the cheek cell sample is to collect genetic (DNA) material that may show what, if anything, might be different or unusual about a child who gets hepatoblastoma, or about his/her home environment or his/her DNA. DNA is the genetic material in a person's cells that makes them unique. DNA is found in your cheek cells. There are thousands of genes in each cell, which are made up of DNA. By studying the DNA, scientists can discover what genes might be involved in the development of disease. An example of how DNA could be used in the fight against cancer is testing whether the absence or presence of certain genes that help break down toxic agents is associated with cancer in children. It is important to remember that this kind of work is exploratory research. There is no clinical or predictive value to the information, so the individual results will not be given to you or your doctor. Group results will be available when the study is complete.

How is my DNA collected?

The cheek cells are gathered by using a soft brush and rubbing the inside of the cheek for children and by collecting a small sample of a mouth wash rinse for mothers. Study staff will mail appropriate supplies to collect DNA samples along with materials and postage to return completed samples.

How and why do you keep/bank the DNA?

This kind of research is fairly new and the methods used to gather information are constantly changing. These samples will be used for research by Logan G. Spector, Ph.D., and his associates for the purposes of learning more about hepatoblastoma. Research that uses your DNA from the cheek cell sample might be done a long time after the cheek cells has been collected. If you give us permission, we will keep the samples so that we can continue to use the most recent tools to gather more information on the risk factors that may be associated with hepatoblastoma. Individuals will not be identified in any publication or reports of this data. If at any time you decide you would like your DNA sample destroyed, please call 1-800-756-1991 and let the study staff know.

How do you keep the information private?

The answers to the interview will be kept separate from your name. The DNA sample is stored with only a number on it. The link between the interview information and DNA sample number and names is kept in a separate file. After the study is completed, the link is destroyed, making the information collected anonymous.

Why do you need my medical records?

Medical records are used to compare the treatments received by children who did and did not develop hepatoblastoma.

What do I get for doing this?

There is no direct benefit for you or your child; however, participating in this kind of research may help to improve people's health. Because the value of the research is not known at this time, the results will not be given to participants or their doctors. All participants receive $10 for participating in the study among completion.

When will the study results be available?

We expect to report the results of this study within the next five years. No individual would ever be identified; all data are coded by identification numbers and only group results are presented.

Can I receive the study results?

Absolutely. Group results will be available a few years after the study is completed. When the interviewer calls you for your telephone interview, let her know that you would like to receive the study results.

What if I have questions?

If you have any questions you can reach study staff at 1-800-756-1991, toll-free.