Bladder Cancer Clinical Trial
Official title:
The New England Bladder Cancer Study
Verified date | July 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
...
Status | Completed |
Enrollment | 2681 |
Est. completion date | July 14, 2020 |
Est. primary completion date | June 16, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 79 Years |
Eligibility |
- INCLUSION CRITERIA: All histologically-confirmed incident cases of carcinoma of the bladder, including carcinoma in situ, between the ages of 30 and 79 years occurring among residents of New Hampshire, Maine and Vermont during an accrual period of about three years are eligible to be included in the study. Controls must be aged 30 to 79, with no previous bladder cancer diagnosis. Individuals with other malignancies will not be excluded. Controls under age 65 will be selected among residents of the three states with valid driving license from the Motor Vehicle Administration (MVA) computer tapes at six-month intervals. Controls aged 65 to 79 will be identified from the Centers for Medicare and Medicaid Services (CMS) files. CMS controls will be selected at six-month intervals over the interviewing period of the study from the most recently available updated tapes. EXCLUSION CRITERIA: Children will be excluded from this study. |
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute (NCI), 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Baris D, Karagas MR, Koutros S, Colt JS, Johnson A, Schwenn M, Fischer AH, Figueroa JD, Berndt SI, Han S, Beane Freeman LE, Lubin JH, Cherala S, Cantor KP, Jacobs K, Chanock S, Chatterjee N, Rothman N, Silverman DT. Nonsteroidal anti-inflammatory drugs and other analgesic use and bladder cancer in northern New England. Int J Cancer. 2013 Jan 1;132(1):162-73. doi: 10.1002/ijc.27590. Epub 2012 May 22. — View Citation
Baris D, Karagas MR, Verrill C, Johnson A, Andrew AS, Marsit CJ, Schwenn M, Colt JS, Cherala S, Samanic C, Waddell R, Cantor KP, Schned A, Rothman N, Lubin J, Fraumeni JF Jr, Hoover RN, Kelsey KT, Silverman DT. A case-control study of smoking and bladder cancer risk: emergent patterns over time. J Natl Cancer Inst. 2009 Nov 18;101(22):1553-61. doi: 10.1093/jnci/djp361. Epub 2009 Nov 16. — View Citation
Garcia-Closas M, Rothman N, Figueroa JD, Prokunina-Olsson L, Han SS, Baris D, Jacobs EJ, Malats N, De Vivo I, Albanes D, Purdue MP, Sharma S, Fu YP, Kogevinas M, Wang Z, Tang W, Tardón A, Serra C, Carrato A, García-Closas R, Lloreta J, Johnson A, Schwenn M, Karagas MR, Schned A, Andriole G Jr, Grubb R 3rd, Black A, Gapstur SM, Thun M, Diver WR, Weinstein SJ, Virtamo J, Hunter DJ, Caporaso N, Landi MT, Hutchinson A, Burdett L, Jacobs KB, Yeager M, Fraumeni JF Jr, Chanock SJ, Silverman DT, Chatterjee N. Common genetic polymorphisms modify the effect of smoking on absolute risk of bladder cancer. Cancer Res. 2013 Apr 1;73(7):2211-20. doi: 10.1158/0008-5472.CAN-12-2388. Epub 2013 Mar 27. — View Citation
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