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CompletedNCT00501280Updated Apr 4, 2013

Genetic Susceptibility in Migrant Farmworker Children

An observational study in Epidemiology, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-04.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
768
Ages
5 Years to 18 Years
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Epidemiology

Keywords

  • Epidemiology
  • Genetic Susceptibility
  • Migrant Farmworker Children
  • Migrant Education Program
  • Interview
  • Questionnaire
03

In context

Disease Susceptibility

141 studies on the registry are indexed under Disease Susceptibility; 31 are open to participants now.

This study's enrollment of 768 is above the median of 200 across 84 observational studies indexed under Disease Susceptibility.

Browse Disease Susceptibility studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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).
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
768 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • MSF Women + their children

    Blood and urine samples and interviews of Migrant or seasonal farmworker (MSF) woman + their children

    Behavioral: Interview

  • 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

    Behavioral: Interview

Interventions

  • BehavioralInterview

    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

    Also known as: Questionnaire

06

What researchers measure

Primary outcomes

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

    Time frame: One time blood/urine collection from each mother/child

07

Study locations

1 site
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00501280
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
Jul 16, 2007
Start date
Jun 2004
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Apr 4, 2013

Study contacts

Maria A. Hernandez, MD
principal investigator · UT MD Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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