Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501280
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2007-07-13
Brief Title:
Genetic Susceptibility in Migrant Farmworker Children
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Biomarkers of Genetic Susceptibility in Environmentally-Exposed MigrantSeasonal Farmworker Women and Their Children
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To test the hypothesis that children whose mothers are MigrantSeasonal 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
1 To test the hypothesis that children whose mothers are MigrantSeasonal 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
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 childs mother if she and her child would like to participate in the study The interviewer will ask each participating mother about her and her childs age childs gender her and her childs 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 mothers 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 childs mother agrees the types and levels of the pesticides detected will be provided to the childs 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 N400 will take part in this study All 800 participants will be enrolled at UT MD Anderson Cancer Center
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 childs mother if she and her child would like to participate in the study The interviewer will ask each participating mother about her and her childs age childs gender her and her childs 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 mothers 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 childs mother agrees the types and levels of the pesticides detected will be provided to the childs 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 N400 will take part in this study All 800 participants will be enrolled at UT MD Anderson Cancer Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None