What is the Infant Study?

The Infant study was designed to try to find things that might cause acute leukemia in infants. Little is known about infant leukemia. Infant leukemia is very rare; only about 35 cases occur in every 1 million pregnancies. It is unknown why infant leukemia happens; it could be due to certain exposures, genetics, a combination of the two, or by chance. Importantly, a certain type of genetic abnormality, called an MLL translocation, is found in about 75% of infant cases. Further, about half of infants with leukemia have acute lymphoblastic leukemia (ALL), while the other half have acute myeloid leukemia (AML).

This is a national study (United States and Canada) 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. The researchers then look for differences between groups of people who develop disease and those who do not.

This is the largest study of infant leukemia 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 infant leukemia?
2. What are the genetic differences between infants who develop leukemia and the infants who do not?
3. How are environmental and genetic factors related in the development of infant leukemia?

What do we hope to gain from this study?

We hope to learn more about the factors that may contribute to the development of infant leukemia. This is done by asking mothers with children who have been diagnosed with leukemia 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 leukemia. The doctors and researchers hope that through very carefully determined questions they might find a common thread among those who have developed infant leukemia (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 infant leukemia. 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 a member of your family was diagnosed with leukemia, registered with the Children's Oncology Group.

Who is eligible for this study?

In order to participate in this study, infants (less than 12 months of age) must be newly diagnosed with acute leukemia (acute lymphoblastic leukemia (ALL), or acute myeloid leukemia (AML)). Additionally, the infant should not have Down syndrome (children with Down syndrome have leukemias that are genetically and biologically different than the leukemias in children without Down syndrome), the patient's physician must give permission to contact the parents of the patient, and the biological mother of the infant must be available, speak English or Spanish, and consent to be interviewed. For newly diagnosed infants, the diagnosis of leukemia must be made between January 1, 2003 and December 31, 2006. Mothers of infants who have been diagnosed within the study period, but are deceased, are eligible to participate. Please consult your doctor to determine whether your child may participate in this study.

How many people will be involved with the study?

The study opened for the first time on May 17, 1999. During this first study phase, 240 mothers of infants with leukemia and 255 mothers of infants without leukemia were enrolled on the study. The study was then closed for a short time; the second phase opened on May 10, 2004 to allow an additional 240 mothers of infants with leukemia and 150 mothers of infants without leukemia pairs to be enrolled. The study is currently open and enrollment will continue through early 2007. It is expected that mothers of 500 infants with leukemia and mothers of 400 children without leukemia (who were born around the same time as the infants with leukemia) 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 an hour or less. We will schedule the interview only at a time that is convenient for you, just let the interviewer know what works best for you. Some moms 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, 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 infants getting leukemia. Only by asking questions such as these can we learn whether any of these factors are important in the development of infant leukemia.

The other part of this study involves an optional collection of cheek cells for DNA analysis from yourself and your infant. If you wish, you can choose not to take part in this part of the study; it is entirely up to you.

What if I completed the interview already?

Some mothers have already participated in the interview portion of the study, but have not been asked if they would be willing to provide DNA samples from themselves and their children with leukemia. These mothers will be contacted and asked to participate in this part of the study.

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 leukemia, 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 or by collecting a small sample of a mouthwash rinse. Infant DNA can also be collected from slides or bone marrow samples that were previously collected at the treating or diagnosing institution. No new slides or bone marrow samples will be collected.

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 Julie A. Ross, Ph.D., and her associates for the purposes of learning more about cancer and similar illnesses. Research that uses your DNA from the cheek cell sample might be done a long time after the mouthwash 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 leukemia. 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 1-800-470-8636 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 a number on it only. 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.

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.

When will the study results be available?

Over 300 mothers such as yourself have already completed the interview. 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 1-800-511-2629, toll-free.