Genetic Susceptibility in Migrant Farmworker Children

NCT00501280 | Completed

• 1 other identifier: 2003-0350
• Study Type: observational
• Target: 768
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 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.
3. 3.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.
4. 4.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.
5. 5.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.
6. 6.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.
7. 7.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.
8. 8.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.

Conditions

Epidemiology

Keywords

Epidemiology; Genetic Susceptibility; Migrant Farmworker Children; Migrant Education Program; Interview; Questionnaire

Outcome Measures

Primary Outcomes (1)

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

  One time blood/urine collection from each mother/child

Study Arms (2)

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

Interview BEHAVIORAL

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

MSF Women + their children; Non-MSF Women + their Children

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Eligibility Criteria for the MSF Children: Children born of MSF women who are currently working in agriculture.
• Enrolled in the Migrant Education Program
• Ages 5-18, no gender restrictions
• Residing in either Baytown (Harris County) or La Joya (Hidalgo County).
• 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
• Whose mothers and/or fathers have never worked in agriculture.
• 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).
• For MSF and non-MSF children: Children who have assented and whose mothers have signed the inform consent for participation in the study.
• 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.
• MSF women who have signed the inform consent for participation in the study.
• 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.
• Non-MSF women who have signed an inform consent for participation in the study.

You may not qualify if:

• Children who do not reside in Baytown or in La Joya, Texas.
• MSF women who do not reside either in Baytown or La Joya and who have not conducted farmwork during the year of recruitment.
• MSF women who do not have children ages 5-18.
• Women who have not signed an informed consent for participation in the study.
• Women who are not MSF but who do not have children ages 5-18 (+/- 2 years).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center official website

Biospecimen

Retention: SAMPLES WITH DNA

10 teaspoons of blood drawn and a urine sample from each mother/child.

MeSH Terms

Conditions

Genetic Predisposition to Disease

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maria A. Hernandez, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 16, 2007
• Study Start: June 1, 2004
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)