Trial Information

Male:Female Birth Ratios and Phthalate Levels Along The Rural Lower Rio Grande Valley (Hidalgo County) and in Baytown, Texas

Questionnaire:

If you agree to take part in this study, you will complete a questionnaire about your
family's characteristics. For example, the questionnaire will have questions about your
educational level, your eating habits, your health conditions, your family's income level,
and how many people live in your house. The study doctor will also ask you questions about
any drugs you may be taking. The questionnaire should take about 30-35 minutes to complete.

The completed paper questionnaire will be placed in a secured, locked cabinet and will be
given a code number. Only the researcher in charge of the study will have access to the
code numbers and be able to link the questionnaire to you. After the study ends and after
information from the questionnaire has been entered in a password protected database, the
paper copy of the questionnaire will be sent to M. D. Anderson to be stored for up to 5
years. After 5 years, it will be destroyed.

Urine Sample:

You will have a urine sample collected. Researchers will study the urine samples to learn
what your level of exposure may be to certain chemicals in the environment, specifically
chemicals called phthalates. Phthalate is the only chemical that will be measured.

Additional Information:

All information collected during this study will be kept strictly confidential, and will not
contain any personal identifiable information such as your name, address, and/or telephone
number. All the information will be will be given a code number. To protect
confidentiality, DNA data will not be linked to participant identifiers. Only the
researcher in charge of the study will have access to the code numbers and be able to link
any information to you. All samples and DNA data will be destroyed within three years
after the conclusion of the study.

Length of Study:

After the questionnaire is complete and the urine sample has been collected, your
participation on this study will be over.

This is an investigational study. Up to 300 participants (150 from Baytown,TX and 150 from
the rural lower Rio Grande Valley in Hidalgo County, TX) will take part in this study. All
will be enrolled through M. D. Anderson.