Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Observational

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.

        -  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).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
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).
      
Keywords: Survival Study; Bladder Cancer; Cancer Recurrence; Tumor Markers/Heterogeneity