Bladder CancerNCT00342875
The New England Bladder Cancer Study
An observational study of Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Bladder Cancer
- How many people
- 2,681 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2002to 14 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).@@@
Who may be able to join
- 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.
Who cannot join
- Children will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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:
Read more
- 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.
...
Read the 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 U.S., 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 1,200 cases and 1,200 controls. Several data collection activities will be incorporated in this study: a self-administered residential/occupational 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.
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Exposure, Drinking Water
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Cancer
Bladder Cancer
Measured: 2001-2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Mar 2002
- Primary completion16 Jun 2004
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,681 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra Silverman, D.Sc., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342875
- Sponsor's protocol ID
- 999902143
- Other IDs
- 02-C-N143
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2006
- Last updated
- 15 Jul 2020
- Results posted
- No
Publications
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.
PubMed 19917915Baris 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.
PubMed 22505343Garcia-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.
PubMed 23536561
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New England Bladder Cancer Study
- ClinicalTrials.gov ID
- NCT00342875
- Acronym / sponsor ID
- 999902143
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Exposure, Drinking Water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,681 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Mar 2002 (actual)
- Primary completion
- 16 Jun 2004 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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 U.S., 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 1,200 cases and 1,200 controls. Several data collection activities will be incorporated in this study: a self-administered residential/occupational 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).@@@
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Children will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bladder Cancer
Time frame: 2001-2004
Bladder Cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 19917915Baris 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.
- Background: PubMed 22505343Baris 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.
- Background: PubMed 23536561Garcia-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.
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Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Silverman, D.Sc. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Cancer (time frame: 2001-2004). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342875, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.