Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01139476
First received: June 5, 2010
Last updated: September 6, 2014
Last verified: August 2014
  Purpose

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.

Condition
Multiple Myeloma
Leukemia
MGUS
MBL

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Study of Biomarkers of Exposure and Effects in Agriculture

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1600
Study Start Date: May 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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).

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".
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139476

Contacts
Contact: Michael Alavanja, Ph.D. (301) 496-9093 alavanjm@mail.nih.gov

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Alavanja, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01139476     History of Changes
Other Study ID Numbers: 999910106, 10-C-N106
Study First Received: June 5, 2010
Last Updated: September 6, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Agriculture Health Study
Multiple Myeloma
MGUS
Leukemia
Biorepository

Additional relevant MeSH terms:
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 14, 2014