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Measuring Surgical Recovery After Radical Cystectomy

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ClinicalTrials.gov Identifier: NCT03193970
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Bladder Cancer Behavioral: Post‐Operative Recovery Registry

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Measuring Surgical Recovery After Radical Cystectomy
Actual Study Start Date : April 30, 2015
Estimated Primary Completion Date : December 2034
Estimated Study Completion Date : December 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort Intervention/treatment
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
Multi‐institutional prospective database of patients with bladder cancer undergoing radical cystectomy.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

N/A


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193970


Contacts
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Contact: Neema Navai, MD 713-792-3950 nnavai@mdanderson.org

Locations
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United States, California
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sima Porten, MD, MPH       Sima.Porten@ucsf.edu   
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Jay Shah, MD       jbshah@stanford.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mehrdad Alemozaffar, MD       malemoz@emory.edu   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Gary D. Steinberg, MD       gsteinbe@surgery.bsd.uchicago.edu   
United States, Kansas
University of Kansas Medical Center Recruiting
Lawrence, Kansas, United States, 66045
Contact: Eugene Lee, MD       elee@kumc.edu   
United States, Maryland
John Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21205
Contact: Trinity Bivalacqua, MD, PhD         
Contact       tbivala1@jhmi.edu   
United States, Michigan
Spectrum Health Medical Group Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Brian Lane, MD       Brian.lane@spectrumhealth.org   
United States, New York
Winthrop University Hospital Not yet recruiting
Mineola, New York, United States, 11501
Contact: Anthony Corcoran, MD       ACorcoran@Winthrop.org   
University of Rochester Recruiting
Rochester, New York, United States, 14611
Contact: Edward Messing, MD       edwardmessing@urmc.rochester.edu   
United States, Texas
University of Texas - Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Yair Lotan, MD       Yair.Lotan@UTSouthwestern.edu   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77339
Contact: Neema Navai, MD       nnavai@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Neema Navai, MD M.D. Anderson Cancer Center

Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03193970     History of Changes
Other Study ID Numbers: PA15-0026
NCI-2018-01433 ( Registry Identifier: NCI CTRP )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Bladder Cancer
Registry
Post‐surgical outcomes
Radical cystectomy
MD Anderson Symptom inventory
MDASI

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases