BloodNCT01547858
Studying Blood Toxicity in Workers Exposed to Formaldehyde
An observational study of Blood and Chemical Industry, run by National Cancer Institute (NCI) at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Blood, Chemical Industry
- How many people
- 708 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2012to 12 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- The eligible age range for the study will be 18 to 60 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-Sectional Study of Hematotoxicity in Workers Exposed to Formaldehyde
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.
Read more
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.
- Conditions
- Blood, Chemical Industry
- Keywords
- Hematotoxicity, Formaldehyde, Cross-Sectional Study, Occupational Exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematotoxicity Change
Complete blood counts
Measured: 2012-2024
Immune Function
immune biomarkers
Measured: 2012- 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study start9 Feb 2012
- Primary completion30 May 2013
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BloodStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Qing Lan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547858
- Sponsor's protocol ID
- 999912055
- Other IDs
- 12-C-N055
- Status last verified
- Nov 2020
- First submitted
- 6 Mar 2012
- Last updated
- 16 Nov 2020
- Results posted
- No
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 14600093Hauptmann 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 19933446Pinkerton 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study of Hematotoxicity in Workers Exposed to Formaldehyde
- ClinicalTrials.gov ID
- NCT01547858
- Acronym / sponsor ID
- 999912055
- Conditions
- Blood, Chemical Industry
- Keywords
- Hematotoxicity, Formaldehyde, Cross-Sectional Study, Occupational Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Feb 2012 (actual)
- Primary completion
- 30 May 2013 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- The eligible age range for the study will be 18 to 60 years old
Key exclusion criteria (2 listed)
- A history of cancer, chemotherapy, and/or radiotherapy, as well as previous or current occupational exposure to benzene, butadiene, styrene and radiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hematotoxicity Change
Time frame: 2012-2024
Complete blood counts
Immune Function
Time frame: 2012- 2024
immune biomarkers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Background: PubMed 14600093Coggon 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.
- Background: PubMed 19933446Hauptmann 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.
- Background: PubMed 14985513Pinkerton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Lan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood and Chemical Industry, run by National Cancer Institute (NCI) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematotoxicity Change (time frame: 2012-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547858, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020; AzTrials last refreshed its copy on 4 Nov 2026.