Male:Female Birth Ratios and Phthalate Levels

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00903318

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

300

Enrollment

Locations

92.9

Actual Duration (Months)

100

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates, among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border region via survey.

Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas Department of Health and the Center for Health Statistics.

Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in Mexican American men and women from urban Baytown, Texas and rural communities along the lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women in each community) from participants who complete the survey in Objective 1.

Condition or Disease	Intervention/Treatment	Phase
Endocrine Diseases	Behavioral: Questionnaire

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 15, 2009

Actual Primary Completion Date :

Feb 9, 2017

Actual Study Completion Date :

Feb 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
Mexican American Men and Women Rural and urban Mexican American men and women , aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border	Behavioral: Questionnaire Questionnaire about family's characteristics taking about 30-35 minutes to complete. Other Names: Survey

Arm

Intervention/Treatment

Mexican American Men and Women

Rural and urban Mexican American men and women , aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border

Behavioral: Questionnaire

Questionnaire about family's characteristics taking about 30-35 minutes to complete.

Other Names:

Survey

Outcome Measures

Primary Outcome Measures

Prevalence of exposure to chemical/toxins (Survey Responses) [3 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and Women of Mexican American origin ages 18 to 40 years
Residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas
Who have signed the informed consent
Individuals will have had to reside in the study area for at least 5 years
Pregnant women are eligible for the study.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Goose Creek Consolidated Independent School District	Baytown	Texas	United States	77521
2	Texas Southern University	Houston	Texas	United States	77004
3	LaJoya Independent School District	La Joya	Texas	United States	78560