Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | June 15, 2010 |
Study of Biomarkers of Exposure and Effects in Agriculture
Background:
- Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often
preceded by a precancerous disorder known as monoclonal gammopathy of undetermined
significance (MGUS). Farmers and other agricultural workers have a higher risk of developing
MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are
interested in studying biological specimens taken from participants in the Agricultural
Health Study - specifically, pesticide applicators at least 50 years of age who do not have
cancer- to better understand the development of MGUS and MM.
Objectives:
- To collect biological specimens from Agricultural Health Study participants for further
research.
- To examine the relationship between pesticide exposure and MGUS/MM.
Eligibility:
- Male pesticide applicators who are over 50 years of age, cancer-free, and participating in
the Agricultural Health Study.
Design:
- Two groups of participants will complete the study: a general group and a smaller group
of individuals who have been exposed to the pesticide diazinon.
- All participants will receive an initial contact letter with information about the
study, followed by a phone call to administer a screening questionnaire and arrange a
home visit from a researcher within the next month.
- Participants will receive by mail a urine specimen kit that will be collected at the
home visit.
- During the home visit, a study researcher will take blood samples and collect the urine
sample, and will administer another questionnaire.
- Participants in the group exposed to diazinon will have three home visits for the study:
(1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and
(3) about 21 days after the second visit. The first visit will take place in the
off-season from January to March; the second and third visits will be conducted between
April and August.
- No treatment will be provided as part of this study.
- Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often
preceded by a precancerous disorder known as monoclonal gammopathy of undetermined
significance (MGUS). Farmers and other agricultural workers have a higher risk of developing
MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are
interested in studying biological specimens taken from participants in the Agricultural
Health Study - specifically, pesticide applicators at least 50 years of age who do not have
cancer- to better understand the development of MGUS and MM.
Objectives:
- To collect biological specimens from Agricultural Health Study participants for further
research.
- To examine the relationship between pesticide exposure and MGUS/MM.
Eligibility:
- Male pesticide applicators who are over 50 years of age, cancer-free, and participating in
the Agricultural Health Study.
Design:
- Two groups of participants will complete the study: a general group and a smaller group
of individuals who have been exposed to the pesticide diazinon.
- All participants will receive an initial contact letter with information about the
study, followed by a phone call to administer a screening questionnaire and arrange a
home visit from a researcher within the next month.
- Participants will receive by mail a urine specimen kit that will be collected at the
home visit.
- During the home visit, a study researcher will take blood samples and collect the urine
sample, and will administer another questionnaire.
- Participants in the group exposed to diazinon will have three home visits for the study:
(1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and
(3) about 21 days after the second visit. The first visit will take place in the
off-season from January to March; the second and third visits will be conducted between
April and August.
- No treatment will be provided as part of this study.
We propose to conduct a molecular epidemiology study with a subset of participants in the
Agricultural Health Study (AHS), a prospective cohort of 57,310 licensed pesticide
applicators in Iowa and North Carolina. Blood and urine samples will be collected from 1,990
cancer-free male AHS participants over the age of 50. These participants will also be asked
to complete a brief interview (approximately 20 minutes) regarding recent exposures and other
lifestyle and health characteristics, which will be conducted at the time of the biospecimen
collection. Participants in both Iowa and North Carolina will be enrolled and home visits for
interviews and sample collection will take place throughout the year between 2010-2014.
The proposed study has two primary objectives. First, we will determine the prevalence and
study the etiology of monoclonal gammopathy of undetermined significance (MGUS), which is a
precursor biomarker for multiple myeloma. We will compare the prevalence of MGUS in the AHS
cohort with the prevalence in two general population-based cohorts ( i.e., Olmsted County and
NHANES IID) with well-characterized MGUS prevalence levels. As a result of previous data
collection efforts in the AHS, comprehensive information on lifetime occupational exposures
and lifestyle factors will be available for the subjects included in this study. We will
examine the associations between MGUS and lifetime exposure to specific pesticides within the
AHS cohort. We will also evaluate several other biomarkers, including telomere length and
global DNA hypomethylation in peripheral blood lymphocytes, for associations with specific
pesticides and excess risk of MGUS.
The second objective is to establish a resource with the remaining blood and urine samples
collected from the participants in this study. These biospecimens will be used to evaluate
the biological plausibility and the mechanism-of-action of associations between pesticides
and cancers observed in earlier AHS studies. Many of these pesticides are non-genotoxic and
their mechanism of carcinogenesis has not been determined. One such future study involving
repository samples will be an investigation of monoclonal B-cell lymphocytosis (MBL), a
marker which has been shown to precede chronic lymphocytic leukemia in previous studies.
Several pesticides in current widespread use in the AHS have been linked to leukemia. We will
determine the prevalence of MBL in the AHS cohort and evaluate potential associations with
specific pesticides of interest to better explain the relation between pesticide exposures
and leukemia risk.
Agricultural Health Study (AHS), a prospective cohort of 57,310 licensed pesticide
applicators in Iowa and North Carolina. Blood and urine samples will be collected from 1,990
cancer-free male AHS participants over the age of 50. These participants will also be asked
to complete a brief interview (approximately 20 minutes) regarding recent exposures and other
lifestyle and health characteristics, which will be conducted at the time of the biospecimen
collection. Participants in both Iowa and North Carolina will be enrolled and home visits for
interviews and sample collection will take place throughout the year between 2010-2014.
The proposed study has two primary objectives. First, we will determine the prevalence and
study the etiology of monoclonal gammopathy of undetermined significance (MGUS), which is a
precursor biomarker for multiple myeloma. We will compare the prevalence of MGUS in the AHS
cohort with the prevalence in two general population-based cohorts ( i.e., Olmsted County and
NHANES IID) with well-characterized MGUS prevalence levels. As a result of previous data
collection efforts in the AHS, comprehensive information on lifetime occupational exposures
and lifestyle factors will be available for the subjects included in this study. We will
examine the associations between MGUS and lifetime exposure to specific pesticides within the
AHS cohort. We will also evaluate several other biomarkers, including telomere length and
global DNA hypomethylation in peripheral blood lymphocytes, for associations with specific
pesticides and excess risk of MGUS.
The second objective is to establish a resource with the remaining blood and urine samples
collected from the participants in this study. These biospecimens will be used to evaluate
the biological plausibility and the mechanism-of-action of associations between pesticides
and cancers observed in earlier AHS studies. Many of these pesticides are non-genotoxic and
their mechanism of carcinogenesis has not been determined. One such future study involving
repository samples will be an investigation of monoclonal B-cell lymphocytosis (MBL), a
marker which has been shown to precede chronic lymphocytic leukemia in previous studies.
Several pesticides in current widespread use in the AHS have been linked to leukemia. We will
determine the prevalence of MBL in the AHS cohort and evaluate potential associations with
specific pesticides of interest to better explain the relation between pesticide exposures
and leukemia risk.
- INCLUSION CRITERIA:
Selected participants in the Agricultural Health Study are invited to participate in this
aspect of the study.
1. Male private pesticide applicator;
2. Alive as of the latest update of the National Death Index G\fDD and over 50 years of
age at the time of initial contact:
3. Cancer free as of the most recent linkage with the appropriateCancer Registry;
4. Completed phase I, II and III interviews (these study subjects have the most
comprehensive exposure evaluation and also will be the most interested in the study).
EXCLUSION CRITERIA:
1. Deceased or no longer residing in Iowa or North Carolina;
2. Ever diagnosed with any type of cancer other than non-melanoma skin cancer;
3. Unable to speak English;
4. Have a blood clotting disorder such as hemophilia; or
5. Registered with the AHS as a "no contact".
We found this trial at
1
site
University of Iowa With just over 30,000 students, the University of Iowa is one of...
Click here to add this to my saved trials
