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Life sciences · Observational Study
ClinicalTrials.gov · October 27, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT00340405). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 9759 participants (ACTUAL). Conditions: Lung Cancer. Primary outcome measures: Identification, validation and refinement of potential early markers of lung cancer , 12/31/2040. Brief summary: 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....