Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study

NCT02298998 | Completed DMC

• 1 other identifier: HSC20130177H
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on the American Urological Association (AUA) guidelines.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.

  2 years

• Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.

  2 years

Secondary Outcomes (2)

• Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.

  2 years

• Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.

  2 years

Study Arms (2)

Intervention

The intervention group refers to surveillance based on the EAU guidelines.

Other: Intervention

Control

The control group refers to surveillance based on the AUA guidelines.

Other: Control

Interventions

Intervention OTHER

Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.

Also known as: EAU surveillance

Intervention

Control OTHER

Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.

Also known as: AUA Surveillance

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a history of low or low-intermediate risk non-muscle invasive bladder cancer. They are being followed with periodic examinations of their bladder as a means for cancer surveillance.

You may qualify if:

• Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer.
• Must have a negative cystoscopy following most recent biopsy.
• Must be able to give informed consent.
• Must be age 18 or older.
• Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines.

You may not qualify if:

• Have a history of invasive (\>=T1) bladder cancer.
• Have a history of carcinoma-in-situ (CIS).
• Unable to give informed consent.
• \< 18 or younger.
• Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements).
• Had a surveillance cystoscopy following most recent biopsy.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

After participant signs the consent form, research staff may ask participant to provide a urine sample at each study visit for research purposes.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Methods

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 24, 2014
• Study Start: March 1, 2013
• Primary Completion: May 28, 2021
• Study Completion: June 7, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

US (1)