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Study Summary
No. 2003-0350:.......Other Studies......Maria A. Hernandez......Health Disparities Research
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Study Summary Title
Study Summary
Number:
2003-0350
Study Title:Biomarkers of Genetic Susceptibility in Environmentally-Exposed Migrant/Seasonal Farmworker Women and their Children
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Physician New Patient Referral
Name:Maria A. HernandezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Health Disparities ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-4009
Contact us about clinical trials
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General Information
Disease Group:Other StudiesSupported By:N/A
Phase of Study:N/AReturn
Visit:
N/A
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of the study is to find out if exposure to pesticides plays a role in
the development of illnesses in MSF women and their children who are exposed to
pesticides through farmwork.
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Study Objectives / Outcomes
Primary Objective 1a: To test the hypothesis that children whose mothers are 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.

Primary Objective 1b: 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 Objective 1a: 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.

Secondary Objective 1b: 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.

Secondary Objective 2a: To test the hypothesis that the total concentration levels of polychorinated biphenyls (PCBs), organochlorine (OCP) and organophosphate (OP) pesticides will correlate with the mutagenic potency of the serum and urine of the children.

Secondary Objective 2b: To test the hypothesis that the total concentration levels of PCB, OCP and OP pesticides will correlate with the mutagenic potency of the serum and urine of the mothers.


Secondary Objective 3a: 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.

Secondary Objective 3b: 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.
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Study Status Information
Study Activation / Registration Date:06/01/2004
IRB Review and Approval Date:09/17/2003
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:800 for the 4-year duration of the study
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 Popualtion: 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) 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 Districit, 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).

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Links
Registration Number: NCT00501280
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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