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CompletedNCT00342472Updated Dec 11, 2020

Environmental and Biological Monitoring Pilot Study for Polycyclic Aromatic Hydrocarbons in Linxian, China

An observational study in Esophageal Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-11.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
81
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (PAHs) are contributing to the high rate of esophageal cancer in Linxian, China.

Esophageal cancer is one of the most fatal cancers worldwide with Linxian, China having one of the highest rates in the world. In the United States esophageal cancer causes approximately 10,000 deaths each year. It is the fourth most common cause of cancer death in black males and the eighth leading cause of cancer death in men of all races. Although several recent studies have identified some of the molecular changes associated with esophageal cancer, its prevention and treatment within high risk groups continues to be limited by our inability to identify specific etiologic agents.

Human exposure to PAHs, including benzo [a]pyrene (B[a]P), is associated with an increased rate of skin, lung, and upper GI tumors and also with an increased mortality from causes related to atherosclerosis. Evidence, including the preliminary results from histologic and food analysis pilot studies, supports the idea that this region's high rate of esophageal cancer may be related to long-term, high-level exposure to PAHs via inhalation of air-borne pollution and ingestion of food cooked with soft coal.

Thus, to assess the association of PAHs with the high rate of esophageal cancer in Linxian, China, we plan to analyze samples of food for the presence of PAHs, samples of blood for Hb adducts (a marker of long-term PAH exposure), samples of urine for 1-OH-Pyrene glucuronide (a maker of short-term PAH exposure), and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and type of stove and/or heating unit (i.e., vented versus unvented), and time spent cooking.

Read the detailed description

The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (P AHs) or acetaldehyde are contributing to the high rate of esophageal cancer in Linxian, China.

Esophageal cancer is one of the most fatal cancers worldwide and Linxian, China has some of the highest rates of this cancer in the world. In the United States esophageal cancer causes approximately 14,000 deaths each year. It is the fourth most common cause of cancer death in black males and the eighth leading cause of cancer death in men of all races. The prevention and treatment of esophageal cancer within high risk groups continues to be limited by our inability to identify specific etiologic agents.

Human exposure to PAHs, including benzo[a]pyrene (B [a]P) is associated with increased rates of skin, lung, esophageal and gastric tumors and also with an increased mortality from causes related to atherosclerosis. Preliminary results from histologic and food analysis pilot studies supports the possibility that the high rates of esophageal cancer in Linxian may be related to long-term, high level exposure to PAHs via inhalation of air-borne pollution and ingestion of food cooked with soft coal.

Exposure to acetaldehyde could also be an etiologically significant exposure in Linxian. Acetaldehyde is a carcinogenic metabolite, and small quantities of ethanol where recently found in homogenized Linxian food samples. The Salaspuro laboratory at the University of Helsinki has demonstrated that oral bacteria can produce acetaldehyde from food containing similar small concentrations of ethanol, so such acetaldehyde exposure could be etiologically significant in Linxian. Genetic polymorphisms, particularly those involving alcohol and acetaldehyde dehydrogenases, may also influence the effect of this exposure.

To assess the association of PAHs and acetaldehyde with the high rate of esophageal cancer in Linxian, China, we plant o analyze samples of food for the presence of PAHs, ethanol and acetaldehyde, samples of blood for Hb and DNA adducts( markers of long-term PAH or acetaldehyde exposure), samples of urine for 1-OH-Pyrene glucuronide (a marker of short term PAH exposure) samples of saliva for acetaldehyde and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and types of stove and/or heating units, and the time spent cooking.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal Cancer
  • Polycyclic Aromatic Hydrocarbons
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 81 is below the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China and, to the extent that is possible, from appropriately age matched controls from a total of 20 nonsmoking individuals from the low-risk region of Gejiu, Yunnan province will be selected to participate.

Eligibility criteria

  • INCLUSION CRITERIA:

Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China and, to the extent that is possible, from appropriately age matched controls from a total of 20 nonsmoking individuals from the low-risk region of Gejiu, Yunnan province will be selected to participate.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
81 participants (actual)

Groups and cohorts

  • 1

    Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China

06

What researchers measure

Primary outcomes

  1. PAH exposure

    To assess the association of PAHs and acetaldehyde with the high rate of esophageal cancer in Linxian, China, we plant to analyze samples of food for the presence of PAHs, ethanol and acetaldehyde,samples of blood for Hb and DNA adducts( markers of longterm PAH or acetaldehyde exposure), samples of urine for 1-OH-Pyrene glucuronide (a marker of short term PAH exposure) samples of salivafor acetaldehyde and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and types of stove and /or heating units, and the time spent cooking.

    Time frame: single time point, when samples are collected

07

Study locations

1 site
  • Chinese Academy of Medical Sciences
    Beijing, China
08

References and documents

Publications

  • Li JY. Epidemiology of esophageal cancer in China. Natl Cancer Inst Monogr. 1982;62:113-20. PubMed 7167171 ↗
  • Ronneberg A, Andersen A. Mortality and cancer morbidity in workers from an aluminium smelter with prebaked carbon anodes--Part II: Cancer morbidity. Occup Environ Med. 1995 Apr;52(4):250-4. doi: 10.1136/oem.52.4.250. PubMed 7795740 ↗
  • Mumford JL, He XZ, Chapman RS, Cao SR, Harris DB, Li XM, Xian YL, Jiang WZ, Xu CW, Chuang JC, et al. Lung cancer and indoor air pollution in Xuan Wei, China. Science. 1987 Jan 9;235(4785):217-20. doi: 10.1126/science.3798109. PubMed 3798109 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00342472
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 21, 2006
Start date
Feb 12, 1998
Primary completion
Jan 1, 2020
Completion
Jun 5, 2020
Last update
Dec 11, 2020

Study contacts

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

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

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