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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00342472
Collaborator
(none)
81
1
267.7
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    81 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Environmental and Biological Monitoring Pilot Study for Polycyclic Aromatic Hydrocarbons in Linxian, China
    Actual Study Start Date :
    Feb 12, 1998
    Actual Primary Completion Date :
    Jan 1, 2020
    Actual Study Completion Date :
    Jun 5, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. PAH exposure [single time point, when samples are collected]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese Academy of Medical Sciences Beijing China

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Sanford M Dawsey, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00342472
    Other Study ID Numbers:
    • 999998008
    • OH98-C-N008
    First Posted:
    Jun 21, 2006
    Last Update Posted:
    Dec 11, 2020
    Last Verified:
    Dec 1, 2020
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 11, 2020