Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health

NCT00776178 | Completed

• 2 other identifiers: 99990900709-C-N007
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

Survival Study; Bladder Cancer; Cancer Recurrence; Tumor Markers/Heterogeneity

Outcome Measures

Primary Outcomes (1)

• There is no intervention. We are looking at survival.

  Overall Survival

  September 30, 2015

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• We will exclude from the feasibility study the following NESEH case participants:
• 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)

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)

• 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.

  PMID: 9144896 BACKGROUND

• Holmang 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.

  PMID: 7752327 BACKGROUND

• Sylvester 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.

  PMID: 16442208 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

• Stella Koutros

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2008
• First Posted: October 21, 2008
• Study Start: October 17, 2008
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

US (1)