NCT00340405

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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,759

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1992

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 1992

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
19.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 7, 2026

Status Verified

January 22, 2026

Enrollment Period

33.6 years

First QC Date

June 19, 2006

Last Update Submit

May 6, 2026

Conditions

Keywords

BloodLung CancerOccupational ExposureRadonArsenicNatural History

Outcome Measures

Primary Outcomes (1)

  • Identification, validation and refinement of potential early markers of lung cancer

    Examining sputum microbiome

    12/31/2040

Study Arms (1)

Tin Miners in China at risk of lung cancer

Tin Miners in China at risk of lung cancer

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Yunnan Tin Corporation (YTC), located in Yunnan Province in southern China, is a large, nonferrousmetals 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).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of the Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (4)

  • Qiao YL, Taylor PR, Yao SX, Erozan YS, Luo XC, Barrett MJ, Yan QY, Giffen CA, Huang SQ, Maher MM, Forman MR, Tockman MS. Risk factors and early detection of lung cancer in a cohort of Chinese tin miners. Ann Epidemiol. 1997 Nov;7(8):533-41. doi: 10.1016/s1047-2797(97)00115-4.

    PMID: 9408549BACKGROUND
  • Qiao YL, Tockman MS, Li L, Erozan YS, Yao SX, Barrett MJ, Zhou WH, Giffen CA, Luo XC, Taylor PR. A case-cohort study of an early biomarker of lung cancer in a screening cohort of Yunnan tin miners in China. Cancer Epidemiol Biomarkers Prev. 1997 Nov;6(11):893-900.

    PMID: 9367062BACKGROUND
  • Taylor PR, Qiao YL, Schatzkin A, Yao SX, Lubin J, Mao BL, Rao JY, McAdams M, Xuan XZ, Li JY. Relation of arsenic exposure to lung cancer among tin miners in Yunnan Province, China. Br J Ind Med. 1989 Dec;46(12):881-6. doi: 10.1136/oem.46.12.881.

    PMID: 2611163BACKGROUND
  • Fan YG, Hu P, Jiang Y, Chang RS, Yao SX, Wang W, He J, Prorok P, Qiao YL. Association between sputum atypia and lung cancer risk in an occupational cohort in Yunnan, China. Chest. 2009 Mar;135(3):778-785. doi: 10.1378/chest.08-1469.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christian C Abnet, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

April 30, 1992

Primary Completion

November 25, 2025

Study Completion

December 31, 2025

Last Updated

May 7, 2026

Record last verified: 2026-01-22

Locations