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


N/A
18 Years
40 Years
Open (Enrolling)
Both
Endocrine Diseases

Thank you

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.


Inclusion Criteria:



1. Men and Women of Mexican American origin ages 18 to 40 years

2. Residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas

3. Who have signed the informed consent

4. Individuals will have had to reside in the study area for at least 5 years

5. Pregnant women are eligible for the study.

Exclusion Criteria:

1) None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Prevalence of exposure to chemical/toxins (Survey Responses)

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Richard A. Hajek, PHD, MS, BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0742

NCT ID:

NCT00903318

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Endocrine Diseases
  • Endocrine
  • Environmental Chemicals
  • Male:Female Birth Ratio
  • Phthalate Exposure
  • Generational sex ratio trends
  • Mexican American
  • Baytown
  • Rio Grande Valley
  • Hidalgo County
  • Texas
  • Endocrine System Diseases

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030