About the Study
Why is this study important?
Our study aims to find the causes of testicular germ cell tumors (TGCT) and determine which men are likely to develop TGCT. Most men get TGCT when they are young, between the ages of 20 and 40. Despite the high survival rate of TGCT, the disease takes many years of youth and health from the men it affects. We hope that by identifying the men most likely to get TGCT, we can better treat and eventually prevent the disease. The National Institutes of Health are sponsoring our research.
Who can participate in the study?
We are recruiting two groups of men: men with TGCT and men without TGCT. These two groups of men will be very much the same in other respects. Studying two groups of men who are similar except for their cancer diagnosis will help us to identify differences between men who do and do not have TGCT.
We are recruiting men with testicular cancer (our 'cases') from hospitals in Philadelphia and the surrounding counties. We are recruiting men without TGCT (our 'controls') from the same area using random address based sampling.
Given the possible genetic and environmental components of TGCT, we are also interested in gathering data from the parents of our 'cases'.
What do study volunteers have to do?
All participants in the study are asked to provide certain materials. They include:
- A Risk Factor Questionnaire. This confidential questionnaire, identified only with a study ID number, takes approximately 15 minutes to complete. The questionnaire asks about personal and family medical history, employment and social history, and exposures currently thought to be risk factors for TGCT.
- A Biospecimen. Participants are asked to contribute either 45 milliliters (about 3 tubes) of blood or two milliliters of saliva. These samples enable us to investigate DNA and look for differences between men who do and do not have TGCT. Additionally, the samples my highlight similarities in DNA between parents and their sons.
- Medical Records. These documents, requested only for study participants with TGCT, are used to learn more about the course of the disease and treatment in men with testicular cancer. We do not analyze the medical records of any other participants.
To thank the participants for helping us with our research, we offer all the men who participate a $25 Best Buy gift card for finishing the study. We are working on additional funding to extend this thank you to parents. The study is reviewed annually for compliance with subject-safety procedures as well as patient privacy protections, and is monitored and approved by the University of Pennsylvania's Institutional Review Board.
How does the study keep our information confidential?
Privacy is very important to us. No personal information is ever provided to anyone outside the study, including insurance companies. All data is kept in encrypted, password-protected databases or in locked files. The study is reviewed annually by the University of Pennsylvania's Institutional Review Board to make sure that we protect subjects' safety and privacy.
What do you do with the DNA?
We examine the DNA to find out if there are differences between men with and without TGCT. Sometimes we look at genes, and sometimes we look at other parts of the DNA. We do not release information to individuals in the study about what we find in their DNA, as none of it would affect their health care. We are interested in looking at ways the groups as a whole are different, rather than examining each person's genetic make-up.