Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study
|First Received Date ICMJE||June 5, 2010|
|Last Updated Date||September 6, 2014|
|Start Date ICMJE||May 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Association between MGUS and specific pesticides within the AHS cohort and whether selected biomarkers are associated with excess MGUS. [ Time Frame: Most participants one time-point (home visit); selected three time-points (home-visit) ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01139476 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study|
|Official Title ICMJE||Study of Biomarkers of Exposure and Effects in Agriculture|
- 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.
- Male pesticide applicators who are over 50 years of age, cancer-free, and participating in the Agricultural Health 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 1,600 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Cross-Sectional|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1600|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Selected participants in the Agricultural Health Study are invited to participate in this aspect of the study.
l. 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 Cancer 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).
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01139476|
|Other Study ID Numbers ICMJE||999910106, 10-C-N106|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP