Development of a Biologic Specimen Bank for the Study of Early Markers of Lung Cancer Among Tin Miners in Yunnan, China

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340405
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

The overall goal of this project is to identify strategies to reduce lung cancer incidence and mortality. Using a high-risk occupational cohort, our specific objectives are 1) to establish a biologic specimen bank and data bank that can be used for the validation and refinement of potential early markers of lung cancer, and 2) to establish a cohort for the study of environmental (including dietary) and genetic risk factors for lung cancer.

Lung cancer is the leading cause of death from malignant neoplasms in the United States and in many countries around the world. Potential strategies to reduce the incidence and mortality of lung cancer include new methods of early detection and identification and alteration of etiologic factors.

The Yunnan Tin Corporation (YTC), located in Yunnan Province in southern China, is a large, nonferrous-metals industry, formed in 1883 and nationalized after the establishment of the People's Republic in 1949. It is involved principally in the production of tin from the mines around the city of Gejiu. The tin miners at YTC have extremely high rates of lung cancer. Among those at high risk, defined as miners 40+ years old with 10+ years of underground mining and/or smelting experience, more than one percent per year develop lung cancer. These extraordinary lung cancer rates result from combined exposure to radon, arsenic, and tobacco smoking in the form of cigarettes and/or bamboo water pipe.

The study population for the development of a biologic specimen bank for the study of early markers of lung cancer is all YTC miners considered to be at high risk for lung cancer based on their occupation exposure (40+ years old with 10+ years of underground or smelting experience). Currently numbering over 7,000, this high-risk group has been the target for the annual lung cancer screening program at the YTC for the past 20+ years. For each high-risk miner, sputum samples are collected annually, read for cytologic interpretation, and stored in Saccomanno's solution for future early marker research. Screening chest x-rays are also obtained. Subjects are followed annually to determine if any have developed lung cancer. Diagnostic workup of suspicious cases includes an additional sputum sample and histology specimen(s), which are used for diagnostic purposes and also retained for future research.

Additional biologic specimens have also been obtained on screenees for etiologic research, including a one-time collection of whole blood, urine, and toenail clippings. Finger stick bloods and buccal smears for DNA will also be sought.


Condition
Lung Cancer

Study Type: Observational
Official Title: Development of a Biologic Specimen Bank for the Study of Early Markers of Lung Cancer Among Tin Miners in Yunnan, China

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 11000
Study Start Date: April 1992
Detailed Description:

The overall goal of this project is to identify strategies to reduce lung cancer incidence and mortality. Using a high-risk occupational cohort, our specific objectives are 1) to establish a biologic specimen bank and data bank that can be used for the validation and refinement of potential early markers of lung cancer, and 2) to establish a cohort for the study of environmental (including dietary) and genetic risk factors for lung cancer.

Lung cancer is the leading cause of death from malignant neoplasms in the United States and in many countries around the world. Potential strategies to reduce the incidence and mortality of lung cancer include new methods of early detection and identification and alteration of etiologic factors.

The Yunnan Tin Corporation (YTC), located in Yunnan Province in southern China, is a large, nonferrous-metals industry, formed in 1883 and nationalized after the establishment of the People's Republic in 1949. It is involved principally in the production of tin from the mines around the city of Gejiu. The tin miners at YTC have extremely high rates of lung cancer. Among those at high risk, defined as miners 40+ years old with 10+ years of underground mining and/or smelting experience, more than one percent per year develop lung cancer. These extraordinary lung cancer rates result from combined exposure to radon, arsenic, and tobacco smoking in the form of cigarettes and/or bamboo water pipe.

The study population for the development of a biologic specimen bank for the study of early markers of lung cancer is all YTC miners considered to be at high risk for lung cancer based on their occupation exposure (40+ years old with 10+ years of underground or smelting experience). Currently numbering over 7,000, this high-risk group has been the target for the annual lung cancer screening program at the YTC for the past 20+ years. For each high-risk miner, sputum samples are collected annually, read for cytologic interpretation, and stored in Saccomanno's solution for future early marker research. Screening chest x-rays are also obtained. Subjects are followed annually to determine if any have developed lung cancer. Diagnostic workup of suspicious cases includes an additional sputum sample and histology specimen(s), which are used for diagnostic purposes and also retained for future research.

Additional biologic specimens have also been obtained on screenees for etiologic research, including a one-time collection of whole blood, urine, and toenail clippings. Finger stick bloods and buccal smears for DNA will also be sought.

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Study participants will be taken from those participating in the annual lung cancer screening examinations conducted by the Labor Protection Institute of the YTC.

Current or retired workers between the ages of 40 and 74.

A history of 10 or more years of underground mining and/or smelting experience.

No proven, active malignancy or serious illness that would interfere with sputum specimen collection.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340405

Locations
China
Cancer Institute of the Chinese Academy of Medical Sciences
Beijing, China, 100021
Yunnan Tin Corporation
Gejiu City, China
Sponsors and Collaborators
Investigators
Principal Investigator: Philip R Taylor, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00340405     History of Changes
Other Study ID Numbers: 9999920168, OH92-C-0168
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Specimen Bank
Sputum
Blood
Urine
Occupational Exposure
Radon
Arsenic
Sputum Bank

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014