Viewing Study NCT00342472



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00342472
Status: COMPLETED
Last Update Posted: 2020-12-11
First Post: 2006-06-19

Brief Title: Environmental and Biological Monitoring Pilot Study for Polycyclic Aromatic Hydrocarbons in Linxian China
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Environmental and Biological Monitoring Pilot Study for Polycyclic Aromatic Hydrocarbons in Linxian China
Status: COMPLETED
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 10000 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 apyrene BaP 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 regions 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 andor heating unit ie vented versus unvented and time spent cooking
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 14000 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 benzoapyrene B aP 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 andor heating units and the time spent cooking

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
OH98-C-N008 None None None