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

NCT00342472 | Completed

• 2 other identifiers: 999998008OH98-C-N008
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Polycyclic Aromatic Hydrocarbons

Outcome Measures

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.

  single time point, when samples are collected

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (3)

• Li JY. Epidemiology of esophageal cancer in China. Natl Cancer Inst Monogr. 1982;62:113-20.

  PMID: 7167171 BACKGROUND

• 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.

  PMID: 7795740 BACKGROUND

• 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.

  PMID: 3798109 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Sanford M Dawsey, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: February 12, 1998
• Primary Completion: January 1, 2020
• Study Completion: June 5, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

CN (1)