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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

Tracking Information
First Submitted Date June 16, 2017
First Posted Date June 21, 2017
Last Update Posted Date May 22, 2019
Actual Study Start Date April 30, 2015
Estimated Primary Completion Date December 2034   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2017)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03193970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Surgical Recovery After Radical Cystectomy
Official Title Measuring Surgical Recovery After Radical Cystectomy
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Condition Bladder Cancer
Intervention Behavioral: Post‐Operative Recovery Registry
Multi‐institutional prospective database of patients with bladder cancer undergoing radical cystectomy.
Study Groups/Cohorts Bladder Cancer Patients Undergoing Radical Cystectomy
Prospective registry of bladder cancer patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating centers.
Intervention: Behavioral: Post‐Operative Recovery Registry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 19, 2017)
20000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2035
Estimated Primary Completion Date December 2034   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Neema Navai, MD 713-792-3950 nnavai@mdanderson.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03193970
Other Study ID Numbers PA15-0026
NCI-2018-01433 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Neema Navai, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019