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Biomarkers of Genetic Susceptibility in Environmentally-Exposed Migrant/Seasonal Farmworker Women and Their Children


N/A
5 Years
18 Years
Not Enrolling
Both
Epidemiology

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Trial Information

Biomarkers of Genetic Susceptibility in Environmentally-Exposed Migrant/Seasonal Farmworker Women and Their Children


Participants in this study are either MSF children and their mothers or non-MSF women (women
who have never worked in agriculture) and their children. If a mother has more than one
child in the school system, only one child can participate in the study. A major effort of
this study is to collect, store and analyze blood and urine samples from MSF women children
and a group of non-MSF women and children. Only the MSF children will be matched by
ethnicity, sex, age (2 or more years), and place of residence to non-MSF children.

All mothers and children participants will be recruited from the school rosters of the Goose
Creek Consolidated Independent School District in Harris County, and the La Joya School
District in Hidalgo County. The names and addresses of all the children and their mothers
are also included in the rosters. Each mother will be contacted by a telephone call or
letter inviting her and her child to participate in the study. If they agree, they will
then be asked if they would like to complete the interview by telephone with the interviewer
from M. D. Anderson or prefer to do the interview at the on-site visit.

A bilingual interviewer will ask each child's mother if she and her child would like to
participate in the study. The interviewer will ask each participating mother about her and
her child's age, child's gender, her and her child's exposure to chemicals, medical history,
places they have lived, places she has worked, family history of disease, reproductive and
breast feeding histories, diet, alcohol and tobacco use. The interview will take from 60 to
70 minutes to complete the mother's and the child participants' questionnaires. All
interviews will be completed by telephone or on-site in the language of choice (English or
Spanish).

Two (2) members of the research team will collect the blood and urine samples, and transport
them to M. D. Anderson since an overnight carrier is not available on the required days of
collection. About 5 teaspoons of blood will be drawn and a urine sample will be collected.
In addition, the height and weight of the mothers and the children will be measured. All
blood and urine collected will be used only by the researchers involved in this study. If
the child's mother agrees, the type(s) and levels of the pesticides detected will be
provided to the child's physician for diagnostic purposes only. The data will be analyzed
in a way that will help maintain confidentiality.

This is an investigational study. A total of 400 children participants and their mothers
(N=400) will take part in this study. All 800 participants will be enrolled at UT MD
Anderson Cancer Center.


Inclusion Criteria:



1. Eligibility Criteria for the MSF Children: Children born of MSF women who are
currently working in agriculture.

2. Enrolled in the Migrant Education Program

3. Ages 5-18, no gender restrictions

4. Residing in either Baytown (Harris County) or La Joya (Hidalgo County).

5. Eligibility Criteria for the non-MSF Children Population : Children attending the ESL
Bilingual Education, Immigrant or Main Stream Programs in the same schools districts
as the MSF Children

6. Whose mothers and/or fathers have never worked in agriculture.

7. Matched to the MSF children population by ethnicity, age plus/minus 2 years, gender,
and residential status (i.e., MSF children in Baytown will be matched to non-MSF
children from Baytown).

8. For MSF and non-MSF children: Children who have assented and whose mothers have
signed the inform consent for participation in the study.

9. Eligibility criteria for MSF women: Women who have children 5-18 years of age who are
currently enrolled in the Migrant Education Programs either in Baytown or La joya,
TX, and who have conducted farmwork during the year of recruitment.

10. MSF women who have signed the inform consent for participation in the study.

11. Eligibility Criteria for Non-MSF women: Women who either themselves or their
children's fathers have not performed farmwork, and whose 5-18 year old children (+/-
2 years) are enrolled in the ESL Bilingual, Immigrant or Main Stream Programs in the
same school districts as the MSF children.

12. Non-MSF women who have signed an inform consent for participation in the study.

Exclusion Criteria:

1. Exclusion for the MSF children: Children who are not enrolled in the Migrant
Education Program from either the Goose Creek Consolidated Independent School
District, or the La Joya Consolidate School District.

2. Children who do not reside in Baytown or in La Joya, Texas.

3. Exclusion for the non-MSF children: Children who are not enrolled in the ESL
Bilingual, Immigrant or Main Stream Programs from Baytown or La Joya, Texas.

4. Exclusion for both MSFs and non-MSF children: Children who have not assented or whose
mothers have not signed the inform consent for study participation.

5. Exclusion for MSF women: Women whose children are not enrolled in the Migrant
Education Program in Baytown or La Joya, Texas.

6. MSF women who do not reside either in Baytown or La Joya and who have not conducted
farmwork during the year of recruitment.

7. MSF women who do not have children ages 5-18.

8. Exclusion for non-MSF women: Women whose children are not enrolled in either the
Bilingual, Immigrant or Main Stream Programs in the school districts of Baytown or La
joya, Tx.

9. Women who have not signed an informed consent for participation in the study.

10. Women who are not MSF but who do not have children ages 5-18 (+/- 2 years).

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

DNA damage [# of chromosome aberrations (CA)] calculated by exposure group

Outcome Time Frame:

One time blood/urine collection from each mother/child

Safety Issue:

No

Principal Investigator

Maria A. Hernandez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0350

NCT ID:

NCT00501280

Start Date:

June 2004

Completion Date:

February 2013

Related Keywords:

  • Epidemiology
  • Epidemiology
  • Genetic Susceptibility
  • Migrant Farmworker Children
  • Migrant Education Program
  • Interview
  • Questionnaire
  • Disease Susceptibility

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030