Genetic Susceptibility in Migrant Farmworker Children

April 1, 2013 updated by: M.D. Anderson Cancer Center

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

Primary Objectives:

  1. To test the hypothesis that children whose mothers are Migrant/Seasonal Farmworkers (MSFs) (occupationally-exposed to pesticides) may be at a higher risk for exhibiting mutagen-induced DNA damage than children whose mothers and fathers are not MSFs.
  2. To test the hypothesis that MSF mothers (occupationally-exposed to pesticides) may be at a higher risk for exhibiting mutagen-induced DNA damage than mothers who are not MSFs.

Secondary Objectives:

  1. To test the hypothesis that both the extent of pesticide exposure and the type of polymorphisms in chemical detoxification genes and DNA repair genes contribute to the extent of cytogenetic damage found in children of MSF women.
  2. To test the hypothesis that both the extent of pesticide exposure and the type of polymorphisms in chemical detoxification genes and DNA repair genes contribute to the extent of cytogenetic damage found in MSF mothers.
  3. To test the hypothesis that the total concentration levels of organochlorine (OCP) and organophosphate (OP) pesticides will correlate with the mutagenic potency of the serum and urine of the children.
  4. To test the hypothesis that the total concentration levels of OCP and OP pesticides will correlate with the mutagenic potency of the serum and urine of the mothers.
  5. To test the hypothesis that inherited polymorphisms in the PON1 gene and its expression modulate the risk for OP genotoxicity measured by the inhibition of the acetylcholinesterase enzyme in MSF children.
  6. To test the hypothesis that inherited polymorphisms in the PON1 gene and its expression modulate the risk for OP genotoxicity measured by the inhibition of the acetylcholinesterase enzyme in MSF mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

768

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Migrant or seasonal farmworker (MSF) woman who has a child attending the Migrant Education Program, or a child of a MSF woman, or a woman who has never worked in agriculture (non-MSF) but has a child attending the ESL Bilingual Education, Immigrant or the Main Stream Programs in the Goose Creek Consolidated School District in Harris County, TX, or in the La Joya School District in Hidalgo County, TX.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MSF Women + their children
Blood and urine samples and interviews of Migrant or seasonal farmworker (MSF) woman + their children
Interview by telephone or on-site in language of choice (English or Spanish), 60 to 70 minutes to complete the mother's and the child participants' questionnaires
Other Names:
  • Questionnaire
Non-MSF Women + their Children
Blood and urine samples and interviews of non-MSF women (women who have never worked in agriculture) and their children
Interview by telephone or on-site in language of choice (English or Spanish), 60 to 70 minutes to complete the mother's and the child participants' questionnaires
Other Names:
  • Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DNA damage [# of chromosome aberrations (CA)] calculated by exposure group
Time Frame: One time blood/urine collection from each mother/child
One time blood/urine collection from each mother/child

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria A. Hernandez, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

April 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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