NCT00342394

Brief Summary

This protocol describes an exposure assessment study of farmers in North Carolina and Iowa who personally apply the fungicides captan, thiophanate-methyl, and benomyl to apple and peach orchards. The exposure assessment will include environmental measurements as well as biological monitoring data. The biomonitoring data will be based on 24-hour urinary metabolites of the three fungicides selected for study. The study is being done in collaboration with the Argicultural Health Study (AHS), a large prospective health study of licensed private (farmer) and commercial applicators, and the spouses of private applicators. The AHS is sponsored by the National Cancer Institute, the National Institute of Environmental Health Sciences and the Environmental Protection Agency. The study described here will be conducted by the National Institute of Occupational Safety and Health. In summary, the objectives of this study are 1) to measure actual exposures to the target fungicides using both environmental and biological measures of exposure, 2) to identify and quantify major determinants of exposure, 3) to describe within- and between-worker exposure variability, and 4) to evaluate, to the extent possible, agreement between exposure estimates computed using the AHS exposure algorithms and exposure estimates based on actual measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 5, 2018

Status Verified

May 1, 2013

First QC Date

June 19, 2006

Last Update Submit

April 4, 2018

Conditions

Keywords

Biological MonitoringExposure DeterminantsExposure ValidationOccupational ExposurePesticidesAgriculture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be recruited from a sub-sample of the AHS cohort.
  • To be eligible for this study, AHS participants must:
  • Currently grow apples or peaches and,
  • Plan to personally apply captan during the spring/summer growing season.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Occupational Safety and Health

Atlanta, Georgia, United States

Location

Related Publications (3)

  • Carter SD, Laskey JW. Effect of benomyl on reproduction in the male rat. Toxicol Lett. 1982 Apr;11(1-2):87-94. doi: 10.1016/0378-4274(82)90111-4.

    PMID: 7090021BACKGROUND
  • Brouwer DH, Brouwer R, De Mik G, Maas CL, van Hemmen JJ. Pesticides in the cultivation of carnations in greenhouses: Part I--Exposure and concomitant health risk. Am Ind Hyg Assoc J. 1992 Sep;53(9):575-81. doi: 10.1080/15298669291360175.

    PMID: 1524032BACKGROUND
  • Barnes TB, Verlangieri AJ, Wilson MC. Reproductive toxicity of methyl-1-(butylcarbamoyl)-2-benzimidazole carbamate (benomyl) in male Wistar rats. Toxicology. 1983 Sep;28(1-2):103-15. doi: 10.1016/0300-483x(83)90110-5.

    PMID: 6636195BACKGROUND

Study Officials

  • Michael Alavanja, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

November 14, 2001

Study Completion

May 1, 2013

Last Updated

April 5, 2018

Record last verified: 2013-05-01

Locations