Urothelial Carcinoma Clinical Trial
— iRARC-KSWOfficial title:
Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age 18 years - informed consent for operation and data use - Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy Exclusion Criteria: - age <18 years - declined informed consent / data use - pregnancy |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Winterthur | Winterthur |
Lead Sponsor | Collaborator |
---|---|
Kantonsspital Winterthur KSW |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative complications | deviations from normal postoperative course ["Clavien-Dindo" Grade] | 1 year | |
Secondary | Treatment of tumor recurrence | Treatment of tumor recurrence (radiotherapy, chemotherapy, operation) | through study completion, an average of 5 years | |
Secondary | Quality of Life urology specific | EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer | 1 year | |
Secondary | Quality of Life overall | EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients | 1 year | |
Secondary | Operation Time | duration of operation [min] | expected 4-8 hours | |
Secondary | Postoperative Death by any cause | Death by any cause [n/months] | through study completion, an average of 5 years | |
Secondary | Pouch capacity | interventional measurement of pouch capacity with pressure recording catheter [ml] | 1 year | |
Secondary | Type of tumor-recurrence | Location of tumor recurrence (local, metastasis) | through study completion, an average of 5 years | |
Secondary | Blood loss | blood loss during operation [ml] | expected 4-8 hours | |
Secondary | Time to recurrence | time until recurrence of tumor [months] | through study completion, an average of 5 years | |
Secondary | Tumor specific death | Time to tumor specific death [months] | through study completion, an average of 5 years | |
Secondary | Preoperative Tumor staging | Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System) | 90 days | |
Secondary | Postoperative Tumor staging | Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System) | 90 days | |
Secondary | Pouch-pressure | interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter | 1 year | |
Secondary | Postvoid residual urine | Residual urin after voiding [ml] | 1 year | |
Secondary | Functional length of urethral sphincter | interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter | 1 year | |
Secondary | Functional pressure of urethral sphincter | interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
Recruiting |
NCT05775874 -
A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC
|
Phase 2 | |
Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
Recruiting |
NCT04617756 -
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
|
Phase 2 | |
Recruiting |
NCT06116396 -
Liquid Biospy for Urinary Cancers
|
||
Recruiting |
NCT05723991 -
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
|
Phase 4 | |
Active, not recruiting |
NCT03039413 -
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
|
Early Phase 1 | |
Completed |
NCT02795156 -
Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations
|
Phase 2 | |
Terminated |
NCT03915405 -
KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT05911295 -
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
|
Phase 3 | |
Terminated |
NCT01093066 -
Prospective Multicentric Evaluation of a Bladder Preservation Strategy
|
Phase 2 | |
Terminated |
NCT01042795 -
Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
|
Phase 2 | |
Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
Recruiting |
NCT03212404 -
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 |