Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study

NCT01139476 | Completed

• 2 other identifiers: 99991010610-C-N106
• Study Type: observational
• Target: 1,892
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Leukemia; MGUS; Monoclonal B-Cell Lymphocytosis

Keywords

Multiple Myeloma; MGUS; Leukemia; Biorepository; Natural History

Outcome Measures

Primary Outcomes (1)

• No intervention; looking for associations between MGUS and specific pesticides within the AHS cohort and whether selected biomarkers are associated with excess MGUS

  To collect biological specimens from Agricultural Health Study participants for further research. To examine the relationship between pesticide exposure and MGUS/MM.

  Most participants receive specimen collection at one time-point (home visit); selected participants receive specimen collection at three time-points (home-visit)

Secondary Outcomes (1)

• Establish a resource with the remaining biospecimens collected from the participants of the MGUS study that will be used to evaluate the biological plausibility and the mechanism-of-action of associations between pesticides and cancers in earlie...

  Ongoing

Study Arms (2)

AHS BEEA participants

A subset of 1990 AHS cohort members who are male private pesticide applicators, living and over 50 years of age at the time contact, cancer free, and who completed AHS Phases IIII.

Non-AHS BEEA participants

A group of 225 age-, race-, and countymatched, non-AHS controls, who have not lived or worked on a farm as an adult, or held a job applying pesticides.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male pesticide applicators who are over 50 years of age, cancer-free, and participating in the Agricultural Health Study. Plus, a small control group comprising individuals who have not worked in agriculture or been occupationally exposed to pesticides.

You may qualify if:

• Selected participants in the Agricultural Health Study are invited to participate in this aspect of the study.
• Male private pesticide applicator;
• 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:
• Cancer free as of the most recent linkage with the appropriateCancer Registry;
• 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).

You may not qualify if:

• Deceased or no longer residing in Iowa or North Carolina;
• Ever diagnosed with any type of cancer other than non-melanoma skin cancer;
• Unable to speak English;
• Have a blood clotting disorder such as hemophilia; or
• Registered with the AHS as a "no contact".

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jonathan N Hofmann, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2010
• First Posted: June 8, 2010
• Study Start: June 15, 2010
• Last Updated: May 1, 2026

Record last verified: 2026-03-18

Locations

US (1)