Epidemiology Clinical Trial
Official title:
Biomarkers of Genetic Susceptibility in Environmentally-Exposed Migrant/Seasonal Farmworker Women and Their Children
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 |
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.
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). |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
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 |
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