The New England Bladder Cancer Study

NCT00342875 | Completed

• 2 other identifiers: 99990214302-C-N143
• Study Type: observational
• Target: 2,681
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Bladder Cancer

Keywords

Bladder Cancer; Exposure; Drinking Water

Outcome Measures

Primary Outcomes (1)

• Bladder Cancer

  Bladder Cancer

  2001-2004

Study Arms (2)

Population Controls

Control subjects were selected randomly from state Department of Motor Vehicle and Centers for Medicare and Medicaid Services (CMS) beneficiary records.

Urinary Bladder Cases

patients with histologically confirmed carcinoma of the urinary bladder

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Case patients included all patients with histologically confirmed carcinoma of the urinary bladder (including carcinoma in situ) newly diagnosed between 2001 and 2004 among residents of Maine, New Hampshire, and Vermont, age 30 to 79 years. Patients were ascertained through hospital pathology departments and hospital and state cancer registries. Control subjects were selected randomly from state Department of Motor Vehicle (DMV) records (age 30-64 years) and Centers for Medicare and Medicaid Services (CMS) beneficiary records (age 65-79 years), frequency matched to case patients by state, sex, and five-year age group at diagnosis. We interviewed 1418 (594 DMV, 824 CMS) control subjects (64.8% of eligible DMV and 64.7% of eligible CMS control subjects).@@@

You may qualify if:

• 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.

You may not qualify if:

• Children will be excluded from this study.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 19917915 BACKGROUND

• 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.

  PMID: 22505343 BACKGROUND

• 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, Tardon A, Serra C, Carrato A, Garcia-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.

  PMID: 23536561 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Debra Silverman, D.Sc.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: March 1, 2002
• Primary Completion: June 16, 2004
• Study Completion: July 14, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

US (1)