NCT03193970

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
103mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Apr 2015Dec 2034

Study Start

First participant enrolled

April 30, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
17.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

19.7 years

First QC Date

June 16, 2017

Last Update Submit

April 10, 2026

Conditions

Keywords

Bladder CancerRegistryPost-surgical outcomesRadical cystectomyMD Anderson Symptom inventoryMDASI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Bladder Cancer Patients Undergoing Radical Cystectomy

Prospective registry of bladder cancer patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating centers.

Behavioral: Post-Operative Recovery Registry

Interventions

Multi-institutional prospective database of patients with bladder cancer undergoing radical cystectomy.

Bladder Cancer Patients Undergoing Radical Cystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.

You may qualify if:

  • \. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California - San Francisco

San Francisco, California, 94143, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

NOT YET RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

University of Kansas Medical Center

Lawrence, Kansas, 66045, United States

RECRUITING

John Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

RECRUITING

Spectrum Health Medical Group

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

Winthrop University Hospital

Mineola, New York, 11501, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14611, United States

RECRUITING

University of Texas - Southwestern

Dallas, Texas, 75390, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77339, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Neema Navai, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neema Navai, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 21, 2017

Study Start

April 30, 2015

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations