Urothelial CarcinomaCYSTECTOMENNCT03677544
Predictive Factorsfor Final Pathologic Ureteral Sections
An observational study of Urothelial Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- laparoscopic approach with an extended pelvic lymph
- How many people
- 748 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
Who may be able to join
- patients > 18 years
- patients reoperative predictive factors for final ureteral section invasion after radical cystectomy
Who cannot join
- patients < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factorsfor Final Pathologic Ureteral Sections on 700 Radical Cystectomy Specimens: Implicationsforintraoperativefrozensection Decision-making
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
Read the 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
- Conditions
- Urothelial Carcinoma
- Being tested
- laparoscopic approach with an extended pelvic lymph
- Keywords
- radical systectomy, Ureteral frozen section
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic approach with an extended pelvic lymphOther
Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation
| Study group | Role | What they receive |
|---|---|---|
| no intraoperative FS examination | Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation. procedures were performed between 1980 and 2013 Receives: Other: laparoscopic approach with an extended pelvic lymph | |
| intraoperative FS examination | Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation procedures were performed between 2001 and 2013 Receives: Other: laparoscopic approach with an extended pelvic lymph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Jan 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Retrospective
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien Saint, PU-PH, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677544
- Sponsor's protocol ID
- PI2017_843_0051
- Acronym
- CYSTECTOMEN
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factorsfor Final Pathologic Ureteral Sections on 700 Radical Cystectomy Specimens: Implicationsforintraoperativefrozensection Decision-making
- ClinicalTrials.gov ID
- NCT03677544
- Acronym / sponsor ID
- CYSTECTOMEN / PI2017_843_0051
- Conditions
- Urothelial Carcinoma
- Keywords
- radical systectomy, Ureteral frozen section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 19 Sep 2018 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no intraoperative FS examination | – | Other: laparoscopic approach with an extended pelvic lymphSurgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation. procedures were performed between 1980 and 2013 |
| intraoperative FS examination | – | Other: laparoscopic approach with an extended pelvic lymphSurgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation procedures were performed between 2001 and 2013 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients > 18 years
- patients reoperative predictive factors for final ureteral section invasion after radical cystectomy
Key exclusion criteria (1 listed)
- patients < 18 years
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 |
|---|---|---|
| laparoscopic approach with an extended pelvic lymphSurgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation | Other | intraoperative FS examination, no intraoperative FS examination |
Primary outcome
preoperative predictive factors
Time frame: 2years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Fabien Saint, PU-PH principal investigator
CHU Amiens-Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative predictive factors (time frame: 2years). 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 16 Jun 2026.