Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy

NCT06891209 | Recruiting

• 2 other identifiers: 23-007176NCI-2025-00372
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores and compares health-related quality of life and urinary outcomes in postoperative partial cystectomy and matched radical cystectomy patients.

Conditions

Bladder Carcinoma

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life - EORTC QLQ-C30

  Assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30), which is designed to measure cancer patients' physical, psychological and social functions. It is a 30-item questionnaire related to symptoms and activities during the past week. Responses are recorded on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Scores among partial cystectomy patients will be compared to radical cystectomy patients.

  Up to 1 year

• Self-reported urinary outcomes

  Assessed using the EORTC Quality of Life Questionnaire - Muscle Invasive Bladder Cancer (EORTC QLQ-BLM30), a 30-item questionnaire related to general symptoms experienced during the past week or during the past 4 weeks. Responses are recorded on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Scores among partial cystectomy patients will be compared to radical cystectomy patients.

  Up to 1 year

Study Arms (2)

Observational - Radical Cystectomy

Patients complete questionnaires and have their medical records reviewed on study.

Other: Non-Interventional Study

Observational - Partial Cystectomy

Patients complete questionnaires and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational - Partial Cystectomy; Observational - Radical Cystectomy

Eligibility Criteria

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

Study Population

Currently living partial cystectomy patients in Mayo Urology's cystectomy registry and patients undergoing radical or partial cystectomy.

You may qualify if:

• Currently living partial cystectomy patients in Mayo Urology's cystectomy registry and patients undergoing radical or partial cystectomy
• Matched 2:1 living radical cystectomy to partial cystectomy patients
• Either urothelial or non-urothelial histology

You may not qualify if:

• Partial cystectomy patients that underwent subsequent radical cystectomy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

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

• Vidit Sharma, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)