Genetic Susceptibility in Migrant Farmworker Children

Epidemiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501280
• Other study ID #: 2003-0350
• Status: Completed
• Phase: N/A
• First received: July 13, 2007
• Last updated: April 1, 2013
• Start date: June 2004
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Susceptibility
• Epidemiology
• Genetic Predisposition to Disease

Intervention

Behavioral:
• Interview
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

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA damage [# of chromosome aberrations (CA)] calculated by exposure group		One time blood/urine collection from each mother/child	No

External Links

•   UT MD Anderson Cancer Center official website