Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352924
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2006-07-14
Brief Title:
Agriculture Health Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Main Agricultural Health Study - A Prospective Study of Cancer and Other Diseases Among Men and Women in Agriculture
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08-16
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 Agricultural Health Study AHS is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences The US Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort
Initial data collection on a prospective cohort of 89658 study subjects has been completed as of December 1997 Participants completed questionnaires that included items on pesticides used other agricultural exposures and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks eg diet exercise alcohol consumption medical conditions family history of cancer other occupations and smoking history Phase II of the study 1998-2003 updated information on occupational exposures diet work practices and medical history by means of a computer assisted telephone interview We also collected buccal cells on sample of 34000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition
The stimulus for this prospective investigation comes from the growing evidence that despite a low mortality overall farmers experience an excess of several cancers These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries Excess cancers are observed for the lymphatic and hematopoietic system connective tissue skin brain prostate stomach and lips Several of these tumors brain NHL multiple myeloma and prostate are also increasing in the general population in many of these countries This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population
Farmers their families and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides solvents fuels and oils engine exhaust dust and zoonotic viruses and other microbes Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers The health effects of pesticide use are the primary focus of the study The influence of other farm exposures are also being evaluated
The focus of the phase II follow-up period 2004-2008 is to update exposure information and health histories by means of a computer assisted interview and also following the cohort to determine disease incidence and mortality The cohort is being followed through the cancer registries within Iowa and North Carolina the Social Security Administration database state vital statistics offices National Death Index and various in-state databases such as the listing of registered pesticide applicators Individuals who enrolled into the study but who are no longer at the address given during enrollment based on subsequent attempts at follow up have been submitted and will continue to be submitted through NIOSH in the standard format to the IRS under their Project 057 Taxpayer Address Request Program Identifying data provided to the IRS include only SSN and the first four letters of last name of cohort member IRS provides in return the most current address in IRS records if a match SSN all four letter of last name is found The purpose of this effort is to identify members of the cohort who have moved out of state to enable adjustment of person-years for incidence and mortality calculations Persons who have moved out of state can be followed for vital status and cause of death but not for cancer incidence
Continuation of the protocol will provide a valuable epidemiologic resource to help prevent cancers in the future by identifying risk factors in the ruralagricultural environment Because more cases of important cancer outcomes occur in this cohort every year potential cancer causes can be evaluated with increased statistical power Larger number of cases also allows for statistical control of confounding factors making more meaningful conclusions about cancer risk and for some relatively infrequent cancers such as the lyphomas and leukemias greater follow-up time is necessary to make any meaningful observations
Initial data collection on a prospective cohort of 89658 study subjects has been completed as of December 1997 Participants completed questionnaires that included items on pesticides used other agricultural exposures and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks eg diet exercise alcohol consumption medical conditions family history of cancer other occupations and smoking history Phase II of the study 1998-2003 updated information on occupational exposures diet work practices and medical history by means of a computer assisted telephone interview We also collected buccal cells on sample of 34000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition
The stimulus for this prospective investigation comes from the growing evidence that despite a low mortality overall farmers experience an excess of several cancers These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries Excess cancers are observed for the lymphatic and hematopoietic system connective tissue skin brain prostate stomach and lips Several of these tumors brain NHL multiple myeloma and prostate are also increasing in the general population in many of these countries This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population
Farmers their families and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides solvents fuels and oils engine exhaust dust and zoonotic viruses and other microbes Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers The health effects of pesticide use are the primary focus of the study The influence of other farm exposures are also being evaluated
The focus of the phase II follow-up period 2004-2008 is to update exposure information and health histories by means of a computer assisted interview and also following the cohort to determine disease incidence and mortality The cohort is being followed through the cancer registries within Iowa and North Carolina the Social Security Administration database state vital statistics offices National Death Index and various in-state databases such as the listing of registered pesticide applicators Individuals who enrolled into the study but who are no longer at the address given during enrollment based on subsequent attempts at follow up have been submitted and will continue to be submitted through NIOSH in the standard format to the IRS under their Project 057 Taxpayer Address Request Program Identifying data provided to the IRS include only SSN and the first four letters of last name of cohort member IRS provides in return the most current address in IRS records if a match SSN all four letter of last name is found The purpose of this effort is to identify members of the cohort who have moved out of state to enable adjustment of person-years for incidence and mortality calculations Persons who have moved out of state can be followed for vital status and cause of death but not for cancer incidence
Continuation of the protocol will provide a valuable epidemiologic resource to help prevent cancers in the future by identifying risk factors in the ruralagricultural environment Because more cases of important cancer outcomes occur in this cohort every year potential cancer causes can be evaluated with increased statistical power Larger number of cases also allows for statistical control of confounding factors making more meaningful conclusions about cancer risk and for some relatively infrequent cancers such as the lyphomas and leukemias greater follow-up time is necessary to make any meaningful observations
Detailed Description:
The Agricultural Health Study AHS is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences The US Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort Initial data collection on a prospective cohort of 89655 study subjects has been completed as of December 1997 Participants completed questionnaires that included items on pesticides used other agricultural exposures and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks eg diet exercise alcohol consumption medical conditions family history of cancer other occupations and smoking history Phase II of the study 1998-2003 updated information on occupational exposures diet work practices and medical history by means of a computer assisted telephone interview We also collected buccal cells on sample of 34000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition The stimulus for this prospective investigation comes from the growing evidence that despite a low mortality overall farmers experience an excess of several cancers These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries Excess cancers are observed for the lymphatic and hematopoietic system connective tissue skin brain prostate stomach and lips Several of these tumors brain NHL multiple myeloma and prostate are also increasing in the general population in many of these countries This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population
Farmers their families and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides solvents fuels and oils engine exhaust dust and zoonotic viruses and other microbes Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers The health effects of pesticide use are the primary focus of the study The influence of other farm exposures are also being evaluated
Farmers their families and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides solvents fuels and oils engine exhaust dust and zoonotic viruses and other microbes Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers The health effects of pesticide use are the primary focus of the study The influence of other farm exposures are also being evaluated
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 |
|---|---|---|---|
| OH93-NC-N013 | None | None | None |