Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2006-06-19
Brief Title:
Development of a Biologic Specimen Bank for the Study of Early Markers of Lung Cancer Among Tin Miners in Yunnan China
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Development of a Biologic Specimen Bank for the Study of Early Markers of Lung Cancer Among Tin Miners in Yunnan China
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11-28
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 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 Peoples 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 andor 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 andor 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 7000 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 Saccomannos 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 specimens 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
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 Peoples 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 andor 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 andor 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 7000 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 Saccomannos 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 specimens 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
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 Peoples 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 andor 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 andor 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 7000 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 Saccomannos 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 specimens 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
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 Peoples 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 andor 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 andor 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 7000 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 Saccomannos 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 specimens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| OH92-C-0168 | None | None | None |