Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342875
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2006-06-19
Brief Title:
The New England Bladder Cancer Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The New England Bladder Cancer Study
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Data from the new cancer atlas covering the period 1974 1994 indicates that deaths from bladder cancer among white men and women are elevated in the northeastern United States particularly the northern parts of New England The reason for these elevated rates of incidence of and deaths from bladder cancer is unknown Only part of the excess risk can be explained by exposure to the textile and leather industries
The purpose of this study is to determine the factors that contribute to the high rates of incidence of and death from bladder cancer in northern New England The main objectives are to
estimate the risk of developing bladder cancer associated with inorganic arsenic in drinking water other water contaminants tobacco use occupational exposures residential proximity to industrial sites dietary factors ethnicity and use of wood-burning stoves
estimate the extent to which water containing inorganic arsenic explains the increased rates of bladder cancer
estimate the extent to which exposure to other risk factors explains the increased rates
evaluate risk of bladder cancer according to genetic factors
examine interactions of these factors with tobacco use occupational exposure and environmental exposure to arsenic and other compounds
All people ages 30 79 with confirmed cases of bladder cancer will be eligible for the study Twelve hundred people with bladder cancer and twelve hundred individuals with no previous bladder cancer will be included
After potential participants are recruited and agreement is obtained over the telephone they will complete a calendar and collect toenail clippings prior to the home interview During the home visit an investigator will administer a computer-assisted personal interview collect drinking water samples and the clippings and obtain a global positioning satellite reading Other biological samples such as saliva samples urine and blood may be requested
Private wells at any previous homes of participants will also be sampled The location of previous homes will be determined and the current homeowner will be asked to allow sampling of the well
The associations between bladder cancer and environmental exposures will be examined and the extent to which exposures to such risk factors explain the elevated mortality and incidence in northern New England will be estimated
The purpose of this study is to determine the factors that contribute to the high rates of incidence of and death from bladder cancer in northern New England The main objectives are to
estimate the risk of developing bladder cancer associated with inorganic arsenic in drinking water other water contaminants tobacco use occupational exposures residential proximity to industrial sites dietary factors ethnicity and use of wood-burning stoves
estimate the extent to which water containing inorganic arsenic explains the increased rates of bladder cancer
estimate the extent to which exposure to other risk factors explains the increased rates
evaluate risk of bladder cancer according to genetic factors
examine interactions of these factors with tobacco use occupational exposure and environmental exposure to arsenic and other compounds
All people ages 30 79 with confirmed cases of bladder cancer will be eligible for the study Twelve hundred people with bladder cancer and twelve hundred individuals with no previous bladder cancer will be included
After potential participants are recruited and agreement is obtained over the telephone they will complete a calendar and collect toenail clippings prior to the home interview During the home visit an investigator will administer a computer-assisted personal interview collect drinking water samples and the clippings and obtain a global positioning satellite reading Other biological samples such as saliva samples urine and blood may be requested
Private wells at any previous homes of participants will also be sampled The location of previous homes will be determined and the current homeowner will be asked to allow sampling of the well
The associations between bladder cancer and environmental exposures will be examined and the extent to which exposures to such risk factors explain the elevated mortality and incidence in northern New England will be estimated
Detailed Description:
Data from the new cancer atlas covering the period 1970-94 indicate that bladder cancer mortality rates among white men and women are elevated in the northeastern US particularly in the northern parts of New England including Maine New Hampshire and Vermont The reasons for these high mortality rates are unclear The persistent elevations in mortality and incidence for bladder cancer among both men and women suggest the possible role of environmental etiologic factors A leading suspect environmental exposure is inorganic arsenic in drinking water which is elevated in private wells in parts of New England The purpose of this study is to determine the risk factors that explain the high mortality and incidence rates for bladder cancer in men and women in northern New England The study will be a population-based case-control study of carcinoma of the urinary bladder in three states New Hampshire Vermont and Maine All histologically-confirmed incident cases of carcinoma of the bladder occurring within a three-year period among residents of the study areas between the ages of 30 and 79 years will be eligible for the study Controls will be selected randomly from the general population of each study area frequency matched to the age- race- and gender-specific distributions of incidence cases of bladder cancer in each state We expect to interview 1200 cases and 1200 controls Several data collection activities will be incorporated in this study a self-administered residentialoccupational history calendar a self-administered diet questionnaire in-person interviews with subjects using a computer-assisted personal interview CAPI collection of drinking water to determine levels of arsenic and other contaminants in drinking water a collection of buccal cells toenails spot urine four-day urinary habits diary overnight urine from a sample of 240 cases and 240 controls and blood from a sample of 180 cases and 180 controls Tumor tissue samples will be obtained for cases We will examine associations between bladder cancer and environmental exposures and estimate the extent to which exposures to such risk factor explain the elevated mortality and incidence in northern New England
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 02-C-N143 | None | None | None |