A Study Comparing the Outcomes of Observation versus Immediate Surgery for Low Risk Bladder Cancer

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-001592
    NCT ID: NCT02700724
    Sponsor Protocol Number: 011222

About this study

This trial is a randomized study comparing effectiveness, morbidity, and cost of observation versus immediate surgery for low grade, noninvasive bladder cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:
    • Total tumor burden ≤ 3cm in size (multiple lesions permitted)
    • Low grade appearance (grade 1 or grade 2)
    • Noninvasive appearance (Ta)
  • No history of carcinoma in situ (CIS) or lesions concerning for CIS
  • Negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)

Exclusion Criteria

  • High grade and/or invasive and/or carcinoma in situ disease
  • Concomitant upper tract urothelial carcinoma
  • Is pregnant or may have plans to become pregnant
  • Positive cytology

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Boorjian, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20267886

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