EpidemiologyNCT00501280
Genetic Susceptibility in Migrant Farmworker Children
An observational study of Epidemiology, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Epidemiology
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 768 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- Children who do not reside in Baytown or in La Joya, Texas.
- 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.
- 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.
- Exclusion for MSF women: Women whose children are not enrolled in the Migrant Education Program in Baytown or 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.
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- MSF women who do not have children ages 5-18.
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers of Genetic Susceptibility in Environmentally-Exposed Migrant/Seasonal Farmworker Women and Their Children
Primary Objectives:
- 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.
- 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.
Read more
Secondary Objectives:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Read the 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 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.
- Conditions
- Epidemiology
- Being tested
- Interview
- Keywords
- Epidemiology, Genetic Susceptibility, Migrant Farmworker Children, Migrant Education Program, Interview, Questionnaire
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Also called Questionnaire
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
| Study group | Role | What they receive |
|---|---|---|
| MSF Women + their children | Blood and urine samples and interviews of Migrant or seasonal farmworker (MSF) woman + their children Receives: 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 Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA damage [# of chromosome aberrations (CA)] calculated by exposure group
Measured: One time blood/urine collection from each mother/child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJun 2004
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpidemiologyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Maria A. Hernandez, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501280
- Sponsor's protocol ID
- 2003-0350
- Status last verified
- Apr 2013
- First submitted
- 13 Jul 2007
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Genetic Susceptibility in Environmentally-Exposed Migrant/Seasonal Farmworker Women and Their Children
- ClinicalTrials.gov ID
- NCT00501280
- Acronym / sponsor ID
- 2003-0350
- Conditions
- Epidemiology
- Keywords
- Epidemiology, Genetic Susceptibility, Migrant Farmworker Children, Migrant Education Program, Interview, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jun 2004
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSF Women + their children | – | Behavioral: InterviewBlood and urine samples and interviews of Migrant or seasonal farmworker (MSF) woman + their children |
| Non-MSF Women + their Children | – | Behavioral: InterviewBlood and urine samples and interviews of non-MSF women (women who have never worked in agriculture) and their children |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
- Children who do not reside in Baytown or in La Joya, Texas.
- 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.
- 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.
- Exclusion for MSF women: Women whose children are not enrolled in the Migrant Education Program in Baytown or La Joya, Texas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAlso: QuestionnaireInterview 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 | Behavioural | MSF Women + their children, Non-MSF Women + their Children |
Primary outcome
DNA damage [# of chromosome aberrations (CA)] calculated by exposure group
Time frame: One time blood/urine collection from each mother/child
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- UT MD Anderson Cancer Center official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria A. Hernandez, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA damage [# of chromosome aberrations (CA)] calculated by exposure group (time frame: One time blood/urine collection from each mother/child). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.