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CompletedNCT01547858Updated Nov 16, 2020

Studying Blood Toxicity in Workers Exposed to Formaldehyde

An observational study in Blood and Chemical Industry, sponsored by National Cancer Institute (NCI). Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-11-16.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
708
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.
Read the detailed description

Research in industrial workers and professionals exposed to formaldehyde suggests that occupational exposure to this important chemical is associated with increased risk for myeloid leukemia. However, there is still uncertainty about the biologic plausibility of the association because of questions regarding the ability of formaldehyde, which is extremely reactive, to directly or indirectly cause toxicity to the bone marrow. There have been several relatively small studies of the impact of occupational formaldehyde exposure on peripheral blood cells that found some evidence that peripheral blood cells of the myeloid lineage (i.e., granulocytes, platelets) were significantly decreased in exposed workers. We propose to follow-up these findings in a relatively large study population in China. We will study hematologic parameters in 240 higher exposed workers (>1 ppm), 240 workers exposed to lower levels of formaldehyde (0.3 to 1 ppm), and a group of 240 unexposed controls frequency-matched to exposed workers. This study will make an important contribution to our understanding of the leukemogenic potential of formaldehyde, which has important public health and regulatory implications.

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Conditions studied

  • Blood
  • Chemical Industry

Keywords

  • Hematotoxicity
  • Formaldehyde
  • Cross-Sectional Study
  • Occupational Exposure
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We will identify formaldehyde-exposed manufacturing workers during the cross-sectional study. The exposed workers have to have held the same job for at least 3 months in the same factory. We expect that the age and sex distribution will be similar in the lower and higher exposed workers. We will enroll controls without previous occupational exposure to formaldehyde or any other genotoxic, hematotoxic or immunotoxic chemicals in two factories that manufacture clothes located in the same@@@geographic area as the utensil producing factories.

Inclusion criteria

  • The eligible age range for the study will be 18 to 60 years old

Exclusion criteria

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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
708 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Hematotoxicity Change

    Complete blood counts

    Time frame: 2012-2024

  2. Immune Function

    immune biomarkers

    Time frame: 2012- 2024

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Study locations

1 site
  • Guangdong National Poison Control Center (NPCC)
    Guangzhour, China
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References and documents

Publications

  • 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. doi: 10.1093/jnci/djg046. PubMed 14600093 ↗
  • 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. PubMed 19933446 ↗
  • 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. doi: 10.1136/oem.2003.007476. PubMed 14985513 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01547858
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
Feb 9, 2012
Primary completion
May 30, 2013
Completion
Nov 12, 2020
Last update
Nov 16, 2020

Study contacts

Qing Lan, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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