Multiple Myeloma Clinical Trial
Official title:
Study of Biomarkers of Exposure and Effects in Agriculture
NCT number | NCT01139476 |
Other study ID # | 999910106 |
Secondary ID | 10-C-N106 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2010 |
Verified date | May 21, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1892 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 100 Years |
Eligibility | - 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". |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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