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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03193970
Other study ID # PA15-0026
Secondary ID NCI-2018-01433
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2015
Est. completion date December 31, 2034

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Neema Navai, MD
Phone 713-792-3950
Email nnavai@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2034
Est. primary completion date December 31, 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers. Exclusion Criteria: N/A

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Post-Operative Recovery Registry
Multi-institutional prospective database of patients with bladder cancer undergoing radical cystectomy.

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States John Hopkins Medical Institutions Baltimore Maryland
United States University of Chicago Chicago Illinois
United States University of Texas - Southwestern Dallas Texas
United States Spectrum Health Medical Group Grand Rapids Michigan
United States University of Texas MD Anderson Cancer Center Houston Texas
United States University of Kansas Medical Center Lawrence Kansas
United States Winthrop University Hospital Mineola New York
United States University of Rochester Rochester New York
United States University of California - San Francisco San Francisco California
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-Surgical Outcomes in Patients Undergoing Radical Cystectomy Post-surgical outcomes determined from patient-reported assessment of symptom burden using the MD Anderson Symptom Inventory (MDASI-BLC form). 3 months
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