Predictive Factorsfor Final Pathologic Ureteral Sections

Urothelial Carcinoma Clinical Trial

— CYSTECTOMEN  

Official title:

Predictive Factorsfor Final Pathologic Ureteral Sections on 700 Radical Cystectomy Specimens: Implicationsforintraoperativefrozensection Decision-making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677544
• Other study ID #: PI2017_843_0051
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: June 1, 2017

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients > 18 years

• patients reoperative predictive factors for final ureteral section invasion after radical cystectomy

Exclusion Criteria:

• patients < 18 years

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Other:
• laparoscopic approach with an extended pelvic lymph
Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative predictive factors	The objective of this study is to identify preoperative predictive factors for final ureteral section invasion after radical cystectomy (RC) and to validate significant factors on an external independent cohort.	2years