Clinical trial NCT03677544: Predictive Factorsfor Final Pathologic Ureteral Sections
Official title: Predictive Factorsfor Final Pathologic Ureteral Sections on 700 Radical Cystectomy Specimens: Implicationsforintraoperativefrozensection Decision-making
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Keywords: radical systectomy
Ureteral frozen section
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In cohort A, most patients did not have intraoperative FS examination although it was performed in some cases depending on the surgeon's habits (N¼92). All patients had intraoperative FS in the validation cohort B. All cystectomies performed for nononcological purposes were excluded. All patients had nonmetastatic bladder cancer on preoperative computed tomography (CT) scans.

Brief summary: To identify preoperative predictive factors for final ureteral section invasion after radical cystotomie (RC) and to validate significant factors on an external independent cohort. The investigators retrospectively reviewed data of all consecutive RC performed for bladder cancer in 2 high-volume institutions. Clinical, pathological, and follow-up data were collected prospectively and reviewed retrospectively. Pathological evaluation was performed by 2 well-trained uropathologists in each center. Logistic regression analyses were performed to identify predictive factors for final ureteral sections involvement. Significant factors in cohort A were validated in cohort B. Receiver operating curve and area under curve were modeled to evaluate predictive accuracy of the markers

Detailed description: To identify preoperative predictive factors for final ureteral section invasion after radical cystotomie (RC) and to validate significant factors on an external independent cohort. Pathological evaluation was performed by 2 well-trained uropathologists in each center (Y.A. and C.C). The investigators retrospectively reviewed data of all consecutive RC performed for bladder cancer in 2 high-volume institutions. Clinical, pathological, and follow-up data were collected prospectively and reviewed retrospectively. Pathological evaluation was performed by 2 well-trained uropathologists in each center. Logistic regression analyses were performed to identify predictive factors for final ureteral sections involvement. Significant factors in cohort A were validated in cohort B. Receiver operating curve and area under curve were modeled to evaluate predictive accuracy of the markers

Eligibility criteria: Inclusion Criteria:

* patients \> 18 years
* patients reoperative predictive factors for final ureteral section invasion after radical cystectomy

Exclusion Criteria:

* patients \< 18 years

Primary outcomes:
measure: preoperative predictive factors
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Fabien Saint, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: