NCT01547858

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

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

February 9, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2013

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

March 6, 2012

Last Update Submit

November 12, 2020

Conditions

BloodChemical Industry

Keywords

HematotoxicityFormaldehydeCross-Sectional StudyOccupational Exposure

Outcome Measures

Primary Outcomes (2)

  • Hematotoxicity Change

    Complete blood counts

    2012-2024

  • Immune Function

    immune biomarkers

    2012- 2024

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- A history of cancer, chemotherapy, and/or radiotherapy, as well as previous or current occupational exposure to benzene, butadiene, styrene and radiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong National Poison Control Center (NPCC)

Guangzhour, China

Location

Related Publications (3)

  • 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.

    PMID: 14600093BACKGROUND

  • 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.

    PMID: 19933446BACKGROUND

  • 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.

    PMID: 14985513BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, buffy coat/Red blood cell, whole blood in PAXgene, Urine, Buccal rinse, Buccal scrape.

Study Officials

  • Qing Lan, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

February 9, 2012

Primary Completion

May 30, 2013

Study Completion

November 12, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

CN(1)