Bladder CancerNCT03193970
Measuring Surgical Recovery After Radical Cystectomy
An observational study of Bladder Cancer, run by M.D. Anderson Cancer Center at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Post-Operative Recovery Registry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Apr 2015to 31 Dec 2034
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Who may be able to join
- 1. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Who cannot join
- N/A
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Mehrdad Alemozaffar, MD, malemoz@emory.edu
- Recruiting
John Hopkins Medical Institutions
Baltimore, Maryland, 21205
Trinity Bivalacqua, MD, PhD
tbivala1@jhmi.edu
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Gary D. Steinberg, MD, gsteinbe@surgery.bsd.uchicago.edu
- Recruiting
University of Texas - Southwestern
Dallas, Texas, 75390
Yair Lotan, MD, Yair.Lotan@UTSouthwestern.edu
- Not yet recruiting
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503
Brian Lane, MD, Brian.lane@spectrumhealth.org
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77339
Neema Navai, MD, nnavai@mdanderson.org
- Recruiting
University of Kansas Medical Center
Lawrence, Kansas, 66045
Eugene Lee, MD, elee@kumc.edu
- Not yet recruiting
Winthrop University Hospital
Mineola, New York, 11501
Anthony Corcoran, MD, ACorcoran@Winthrop.org
- Recruiting
University of Rochester
Rochester, New York, 14611
Edward Messing, MD, edwardmessing@urmc.rochester.edu
- Not yet recruiting
Stanford University
Stanford, California, 94305
Jay Shah, MD, jbshah@stanford.edu
About this study
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.
- Conditions
- Bladder Cancer
- Being tested
- Post-Operative Recovery Registry
- Keywords
- Bladder Cancer, Registry, Post-surgical outcomes, Radical cystectomy, MD Anderson Symptom inventory, MDASI
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Operative Recovery RegistryBehavioural
Multi-institutional prospective database of patients with bladder cancer undergoing radical cystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer Patients Undergoing Radical Cystectomy | Prospective registry of bladder cancer patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating centers. Receives: Behavioral: Post-Operative Recovery Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start30 Apr 2015
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neema Navai, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193970
- Sponsor's protocol ID
- PA15-0026
- Other IDs
- NCI-2018-01433
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2017
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Surgical Recovery After Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03193970
- Acronym / sponsor ID
- PA15-0026
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Registry, Post-surgical outcomes, Radical cystectomy, MD Anderson Symptom inventory, MDASI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Patients Undergoing Radical Cystectomy | – | Behavioral: Post-Operative Recovery RegistryProspective registry of bladder cancer patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Key inclusion criteria (1 listed)
- 1. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-Operative Recovery RegistryMulti-institutional prospective database of patients with bladder cancer undergoing radical cystectomy. | Behavioural | Bladder Cancer Patients Undergoing Radical Cystectomy |
Primary outcome
Post-Surgical Outcomes in Patients Undergoing Radical Cystectomy
Time frame: 3 months
Post-surgical outcomes determined from patient-reported assessment of symptom burden using the MD Anderson Symptom Inventory (MDASI-BLC form).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neema Navai, MD principal investigator
M.D. Anderson Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by M.D. Anderson Cancer Center at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neema Navai, MD (713-792-3950, nnavai@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Surgical Outcomes in Patients Undergoing Radical Cystectomy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.