Bladder CancerNCT00776178
Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health
An observational study of Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Bladder cancer often recurs after treatment and patient survival varies greatly. More knowledge is needed about factors that can help identify patients who are at greater risk of disease recurrence and progression to minimize the need for screening and to help guide treatment. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Bladder Cancer
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2008to 31 Mar 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: The New England Study of Environment and Health (NESEH), a population-based case control study of 1,213 patients in Maine (ME), Vermont (VT), and New Hampshire (NH), provides an excellent opportunity study the clinical, host-genetic, and environmental determinants of prognosis. Bladder cancer patients from ME who participated in the original case-control study (ages 30-79, newly diagnosed with histologically-confirmed carcinoma of the bladder, including carcinoma in situ), excluding those diagnosed after 2003 (5 years of follow-up are needed).
Who may be able to join
- With the exceptions noted below, all bladder cancer patients who participated in the NESEH and were residents of ME when first diagnosed with bladder cancer will be eligible for this feasibility study. Patients were eligible for the NESEH if they met the following criteria:
- 30-79 years old at initial diagnosis
- Newly diagnosed with histologically-confirmed carcinoma of the urinary bladder (including carcinoma in situ) between September 1, 2001 and October 31, 2004
Who cannot join
- We will exclude from the feasibility study the following NESEH case participants:
- 44 bladder cancer patients (7 percent) first diagnosed at one of seven hospitals located in remote areas of ME (Aroostook Medical Center, Calais Regional Hospital, Cary Medical Center, Down East Community Hospital, Houlton Regional Hospital, Northern Maine Medical Center, and Mount Desert Hospital); this is for cost considerations;
- Patients diagnosed fewer than 5 years before the feasibility study begins (i.e., after 2003)
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
Official title: Feasibility Study: Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health
Background:
- Bladder cancer often recurs after treatment and patient survival varies greatly.
- More knowledge is needed about factors that can help identify patients who are at greater risk of disease recurrence and progression to minimize the need for screening and to help guide treatment.
- The New England Study of Environment and Health (NESEH), conducted by the departments of health in Maine, New Hampshire and Vermont, the Dartmouth Medical School and the NIH, examined the relationship between health and environmental factors such as smoking, diet and water quality in New England. This study provides an opportunity to learn more about patients with bladder cancer.
- Before launching a full-scale follow-up study on bladder cancer, it is necessary to determine the feasibility of obtaining needed follow-up information from patients enrolled in the NESEH.
Read more
Objectives:
-To determine the completeness and quality of information about treatment, recurrence, and progression that can be obtained for patients from their medical records.
Eligibility:
-Participants from the NESEH study who are residents of Maine and who were diagnosed with bladder cancer between 2001 and 2003.
Design:
- Determine the vital status of NESEH bladder cancer patients.
- Select a sample of 40 living and 18 deceased patients.
- Interview patients or their next of kin by telephone for about 30 to 45 minutes to update exposure information, obtain names and addresses of all hospitals and physicians they have seen since diagnosis, and obtain authorization to access medical records.
- Obtain and abstract medical records.
Read the detailed description
Background:
- Bladder cancer is a highly recurrent disease with substantial variability in survival.
- Patients currently undergo repeated cystoscopy for many years after diagnosis.
- There is a need to identify prognostic markers of recurrence and progression to minimize the need for routine screening and to identify patients who should be treated more aggressively.
- The New England Study of Environment and Health (NESEH), a population-based case control study of 1,213 patients in Maine (ME), Vermont (VT), and New Hampshire (NH), provides an excellent opportunity study the clinical, host-genetic, and environmental determinants of prognosis.
- Before launching a full-scale follow-up study, we need to determine the feasibility of following a population-based case series and of obtaining patient-related (vital status, exposures) and tumor-related (recurrence, progression, pathology) information.
Objectives:
To determine:
- The completeness and quality of information that can be obtained for each patient. The most important issue is the extent to which medical records from private physicians will be needed, and whether private physicians are cooperative.
- Our ability to identify next-of-kin (NOK) of deceased patients.
- The proportion of patients (and NOK) that we can contact and enroll.
- The ability of NOK to provide information on exposures.
Eligibility:
-Bladder cancer patients from ME who participated in the original case-control study (ages 30-79, newly diagnosed with histologically-confirmed carcinoma of the bladder, including carcinoma in situ), excluding those diagnosed after 2003 (5 years of follow-up are needed).
Design:
- Conduct interviews with 40 living patients and the NOK of 9 deceased patients to update exposure information and find out where the patient received health care, the types of treatment received, and whether and when the disease recurred or progressed.
- For living patients or NOK that we are unable to locate (an estimated 10 living patients and 9 NOK), request medical records from health care providers (to see if physicians will provide records in the absence of an authorization form).
- Evaluate participant and physician response rates and the completeness of the medical history information obtained.
- We will proceed with the full study if we obtain sufficient medical information for 70% of the living patients.
- We will examine whether there were important issues related to deceased patients (e.g., NOK identification/enrollment, exposure assessment, access to medical records). If so, consider a simpler approach for this segment of the population (e.g., survival study based on NDI Plus and information available from the NESEH).
- Conditions
- Bladder Cancer
- Keywords
- Survival Study, Bladder Cancer, Cancer Recurrence, Tumor Markers/Heterogeneity
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
There is no intervention. We are looking at survival.
Overall Survival
Measured: September 30, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study start17 Oct 2008
- Primary completion31 Mar 2020
- Study completion31 Mar 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 only
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stella Koutros, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776178
- Sponsor's protocol ID
- 999909007
- Other IDs
- 09-C-N007
- Status last verified
- Apr 2020
- First submitted
- 18 Oct 2008
- Last updated
- 7 Apr 2020
- Results posted
- No
Publications
Herr HW. Natural history of superficial bladder tumors: 10- to 20-year follow-up of treated patients. World J Urol. 1997;15(2):84-8. doi: 10.1007/BF02201977.
PubMed 9144896Holmang S, Hedelin H, Anderstrom C, Johansson SL. The relationship among multiple recurrences, progression and prognosis of patients with stages Ta and T1 transitional cell cancer of the bladder followed for at least 20 years. J Urol. 1995 Jun;153(6):1823-6; discussion 1826-7.
PubMed 7752327Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
PubMed 16442208
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health
- ClinicalTrials.gov ID
- NCT00776178
- Acronym / sponsor ID
- 999909007
- Conditions
- Bladder Cancer
- Keywords
- Survival Study, Bladder Cancer, Cancer Recurrence, Tumor Markers/Heterogeneity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Oct 2008
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Oct 2008 (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.
Background:
- Bladder cancer often recurs after treatment and patient survival varies greatly.
- More knowledge is needed about factors that can help identify patients who are at greater risk of disease recurrence and progression to minimize the need for screening and to help guide treatment.
- The New England Study of Environment and Health (NESEH), conducted by the departments of health in Maine, New Hampshire and Vermont, the Dartmouth Medical School and the NIH, examined the relationship between health and environmental factors such as smoking, diet and water quality in New England. This study provides an opportunity to learn more about patients with bladder cancer.
- Before launching a full-scale follow-up study on bladder cancer, it is necessary to determine the feasibility of obtaining needed follow-up information from patients enrolled in the NESEH.
Objectives:
-To determine the completeness and quality of information about treatment, recurrence, and progression that can be obtained for patients from their medical records.
Eligibility:
-Participants from the NESEH study who are residents of Maine and who were diagnosed with bladder cancer between 2001 and 2003.
Design:
- Determine the vital status of NESEH bladder cancer patients.
- Select a sample of 40 living and 18 deceased patients.
- Interview patients or their next of kin by telephone for about 30 to 45 minutes to update exposure information, obtain names and addresses of all hospitals and physicians they have seen since diagnosis, and obtain authorization to access medical records.
- Obtain and abstract medical records.
Detailed description
Background:
- Bladder cancer is a highly recurrent disease with substantial variability in survival.
- Patients currently undergo repeated cystoscopy for many years after diagnosis.
- There is a need to identify prognostic markers of recurrence and progression to minimize the need for routine screening and to identify patients who should be treated more aggressively.
- The New England Study of Environment and Health (NESEH), a population-based case control study of 1,213 patients in Maine (ME), Vermont (VT), and New Hampshire (NH), provides an excellent opportunity study the clinical, host-genetic, and environmental determinants of prognosis.
- Before launching a full-scale follow-up study, we need to determine the feasibility of following a population-based case series and of obtaining patient-related (vital status, exposures) and tumor-related (recurrence, progression, pathology) information.
Objectives:
To determine:
- The completeness and quality of information that can be obtained for each patient. The most important issue is the extent to which medical records from private physicians will be needed, and whether private physicians are cooperative.
- Our ability to identify next-of-kin (NOK) of deceased patients.
- The proportion of patients (and NOK) that we can contact and enroll.
- The ability of NOK to provide information on exposures.
Eligibility:
-Bladder cancer patients from ME who participated in the original case-control study (ages 30-79, newly diagnosed with histologically-confirmed carcinoma of the bladder, including carcinoma in situ), excluding those diagnosed after 2003 (5 years of follow-up are needed).
Design:
- Conduct interviews with 40 living patients and the NOK of 9 deceased patients to update exposure information and find out where the patient received health care, the types of treatment received, and whether and when the disease recurred or progressed.
- For living patients or NOK that we are unable to locate (an estimated 10 living patients and 9 NOK), request medical records from health care providers (to see if physicians will provide records in the absence of an authorization form).
- Evaluate participant and physician response rates and the completeness of the medical history information obtained.
- We will proceed with the full study if we obtain sufficient medical information for 70% of the living patients.
- We will examine whether there were important issues related to deceased patients (e.g., NOK identification/enrollment, exposure assessment, access to medical records). If so, consider a simpler approach for this segment of the population (e.g., survival study based on NDI Plus and information available from the NESEH).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The New England Study of Environment and Health (NESEH), a population-based case control study of 1,213 patients in Maine (ME), Vermont (VT), and New Hampshire (NH), provides an excellent opportunity study the clinical, host-genetic, and environmental determinants of prognosis. Bladder cancer patients from ME who participated in the original case-control study (ages 30-79, newly diagnosed with histologically-confirmed carcinoma of the bladder, including carcinoma in situ), excluding those diagnosed after 2003 (5 years of follow-up are needed).
Key inclusion criteria (3 listed)
- With the exceptions noted below, all bladder cancer patients who participated in the NESEH and were residents of ME when first diagnosed with bladder cancer will be eligible for this feasibility study. Patients were eligible for the NESEH if they met the following criteria:
- 30-79 years old at initial diagnosis
- Newly diagnosed with histologically-confirmed carcinoma of the urinary bladder (including carcinoma in situ) between September 1, 2001 and October 31, 2004
Key exclusion criteria (3 listed)
- 44 bladder cancer patients (7 percent) first diagnosed at one of seven hospitals located in remote areas of ME (Aroostook Medical Center, Calais Regional Hospital, Cary Medical Center, Down East Community Hospital, Houlton Regional Hospital, Northern Maine Medical Center, and Mount Desert Hospital); this is for cost considerations;
- Patients diagnosed fewer than 5 years before the feasibility study begins (i.e., after 2003)
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
There is no intervention. We are looking at survival.
Time frame: September 30, 2015
Overall Survival
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 7 Apr 2020.
- Background: PubMed 9144896Herr HW. Natural history of superficial bladder tumors: 10- to 20-year follow-up of treated patients. World J Urol. 1997;15(2):84-8. doi: 10.1007/BF02201977.
- Background: PubMed 7752327Holmang S, Hedelin H, Anderstrom C, Johansson SL. The relationship among multiple recurrences, progression and prognosis of patients with stages Ta and T1 transitional cell cancer of the bladder followed for at least 20 years. J Urol. 1995 Jun;153(6):1823-6; discussion 1826-7.
- Background: PubMed 16442208Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
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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.
Stella Koutros 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 3 inclusion and 3 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 7 Apr 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?
There is no intervention. We are looking at survival. (time frame: September 30, 2015). 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 NCT00776178, 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 7 Apr 2020.