Blood Clinical Trial
Official title:
A Cross-Sectional Study of Hematotoxicity in Workers Exposed to Formaldehyde
Verified date | November 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: - Formaldehyde has many uses in industry and medicine. However, exposure to formaldehyde has been associated with increased risk for myeloid leukemia. There are still questions about how the chemical reacts with bone marrow to increase this cancer risk. Some smaller studies have looked at how it affects stem cells, which are found in bone marrow. Researchers want to develop a much larger study of workers in China. The study will look at different levels of formaldehyde exposure. It will focus on how the chemical affects the blood cells and bone marrow. Objectives: - To study the effects of formaldehyde exposure on blood cells and bone marrow. Eligibility: - Individuals between 18 and 60 years of age who work in selected factories in Guangdong Province, China. Design: - Participants will be screened with a physical exam and medical history. They will also be screened with a work history. Those who have been exposed to benzene, butadiene, styrene, or radiation will not be included. - Participants will be studied based on their regular formaldehyde exposure level. One-third will be those exposed to more than 1 part per million (ppm) of the chemical. One-third will be those exposed to 0.3 to 1 ppm. A control group will have no exposure to formaldehyde or any other known toxic chemical. - Participants will provide blood and cheek swab samples. They will also answer questions about their work habits. - To look at chemical exposure levels, participants will wear a small monitor to work on 3 different days. They may provide additional blood and cell samples as directed. - No treatment will be provided as part of this study.
Status | Completed |
Enrollment | 708 |
Est. completion date | November 12, 2020 |
Est. primary completion date | May 30, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | - INCLUSION CRITERIA: - The eligible age range for the study will be 18 to 60 years old EXCLUSION CRITERIA: Exclusion criteria for both formaldehyde-exposed and control workers will be: - A history of cancer, chemotherapy, and/or radiotherapy, as well as previous or current occupational exposure to benzene, butadiene, styrene and radiation. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong National Poison Control Center (NPCC) | Guangzhour |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
China,
Coggon D, Harris EC, Poole J, Palmer KT. Extended follow-up of a cohort of british chemical workers exposed to formaldehyde. J Natl Cancer Inst. 2003 Nov 5;95(21):1608-15. — View Citation
Hauptmann M, Stewart PA, Lubin JH, Beane Freeman LE, Hornung RW, Herrick RF, Hoover RN, Fraumeni JF Jr, Blair A, Hayes RB. Mortality from lymphohematopoietic malignancies and brain cancer among embalmers exposed to formaldehyde. J Natl Cancer Inst. 2009 Dec 16;101(24):1696-708. doi: 10.1093/jnci/djp416. — View Citation
Pinkerton LE, Hein MJ, Stayner LT. Mortality among a cohort of garment workers exposed to formaldehyde: an update. Occup Environ Med. 2004 Mar;61(3):193-200. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematotoxicity Change | Complete blood counts | 2012-2024 | |
Primary | Immune Function | immune biomarkers | 2012- 2024 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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