Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT01139476
CompletedNCT01139476ClinicalTrials.gov record

Specimen Collection for Agricultural Health Study Cohort Pesticide Exposure Study

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

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - 100 years
Sex eligible
Male
Healthy volunteers
Not accepted
Participants
1892 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.
Read the full 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 1,990 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

  • 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".

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

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

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

Secondary measures

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...

Time frame: Ongoing

Not reported in this registry record.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

University of IowaIowa City, Iowa, United StatesStatus unknown

Study team and timeline

Lead sponsor
National Cancer Institute (NCI)
Study start
Jun 15, 2010
Primary completion
Not reported
Study completion
Not reported
First posted
Jun 8, 2010 Estimated
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Study of Biomarkers of Exposure and Effects in Agriculture

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026