Precancerous Myeloid Cells in Chinese Factory Workers Exposed or Not Exposed to Formaldehyde - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00516763

Purpose

RATIONALE: Exposure to formaldehyde in the work place may affect the risk of developing cancer later in life. Learning about the long-term effects of formaldehyde exposure may help the study of cancer in the future.

PURPOSE: This clinical trial is studying precancerous myeloid cells in workers exposed or not exposed to formaldehyde.

Condition	Intervention
Health Status Unknown	Procedure: DNA methylation analysis Procedure: fluorescence in situ hybridization Procedure: laboratory biomarker analysis Procedure: polymerase chain reaction Procedure: questionnaire administration

MedlinePlus related topics: Cancer

Drug Information available for: Formaldehyde

U.S. FDA Resources

Study Type:	Observational
Official Title:	Protocol for Studies of Myeloid Progenitor Cells in Workers Exposed to Formaldehyde, a Putative Leukemogen

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation of formaldehyde exposure with aneuploidy in myeloid progenitor cells using interphase-FISH, with a particular focus on monosomy of chromosome 7 and aneuploidy of other relevant chromosomes, such as trisomy 8
Correlation of formaldehyde exposure with increased levels of structural aberrations relevant for myeloid leukemogenesis (e.g., 5q-) in myeloid progenitor cells using OctoChrome FISH, which will evaluate aberrations in all 24 chromosomes
Correlation of formaldehyde exposure with epigenetic changes in myeloid progenitor cells, including global methylation and hypermethylation in genes that have been linked to myeloid leukemia, such as p15, HIC1, ER, CDH1, and ABL

Estimated Enrollment:

80

Detailed Description:

OBJECTIVES:

Determine if formaldehyde exposure is associated with aneuploidy in myeloid progenitor cells using interphase-FISH, with a particular focus on monosomy of chromosome 7 and aneuploidy of other relevant chromosomes, such as trisomy 8.
Determine if formaldehyde exposure is associated with increased levels of structural aberrations relevant for myeloid leukemogenesis (e.g., 5q-) in myeloid progenitor cells using OctoChrome FISH, which will evaluate aberrations in all 24 chromosomes.
Determine if formaldehyde is associated with epigenetic changes in myeloid progenitor cells, including global methylation and hypermethylation in genes that have been linked to myeloid leukemia (ML) such as p15, HIC1, ER, CDH1, and ABL.

OUTLINE: This is a cross-sectional study.

Participants complete questionnaires to collect information on lifetime occupational history, environmental exposures that could involve exposure to formaldehyde and other environmental contaminants, medical history, current medications, and past and current tobacco and alcohol use.

Participants exposed to formaldehyde wear a small formaldehyde passive monitor badge on 3 different working days to measure full-shift exposure levels to formaldehyde and a pocket-sized datalogging photoionization detector on 1 of the 3 measurement days to measure continuous formaldehyde exposure to identify and quantify peak exposures. Exposed and unexposed participants wear a passive organic vapor monitor on 1 of the 3 measurement days to measure possible co-exposures to other organic compounds (e.g., aromatic solvents, alkanes).

Participants undergo urine, buccal cell, and blood sample collection periodically for biological studies. Samples are analyzed for the effect of formaldehyde on all 24 chromosomes via FISH, measurement of promoter region hypermethylation via pyrosequencing, and measurement of global DNA methylation via PCR.

PROJECTED ACCRUAL: A total of 40 formaldehyde-exposed and 40 unexposed patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Employee of a factory that manufactures plastic utensils and that has had a stable manufacturing process for the past 5 years AND meets 1 of the following criteria:
- Exposed worker, meeting all of the following criteria:
  - 1-2 ppm formaldehyde exposure on all days during which measurements are taken during cross-sectional study
  - Held the same job for at least one year in the same factory
- Unexposed worker, meeting all of the following criteria:
  - No history of occupational exposure to formaldehyde or other genotoxic, hematotoxic, or immunotoxic chemicals
  - Employed at control factories in the same geographical area as exposed workers

PATIENT CHARACTERISTICS:

Must be of Chinese ethnicity
No history of cancer

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy
No prior occupational exposure to benzene, butadiene, styrene, or radiation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516763

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:	Qing Lan, MD	National Cancer Institute (NCI)
Principal Investigator:	Laura B. Freeman, PhD	National Cancer Institute (NCI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000551662, NCI-06-C-N178
Study First Received:	August 14, 2007
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00516763
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

health status unknown

Study placed in the following topic categories:

Formaldehyde

Additional relevant MeSH terms:

Anti-Infective Agents
Disinfectants
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009