Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02968732|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : May 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Procedure: Radical Cystectomy||Not Applicable|
Archival specimen of prior diagnostic TUR will be prepared as 10-20 unstained 5-10 micron slides to under-go next generation sequencing and be compared to final cystectomy specimen to investigate potential pre-treatment signatures predictive of response to chemotherapy and to understand genomic evolution of primary tumors after chemotherapy. All patients will also have urine, PBMC, and serum/plasma collected at baseline, day of procedure, 4-6 weeks post-procedure, and 6 months post-procedure. The baseline samples will be collected prior to any chemotherapy administration and prior to the procedure.
On the day of the patient's radical cystectomy, standard rigid cystourethroscopy will be performed. A urine sample will be collected from the bladder. A plasma sample will be collected while the patient is under anesthesia or in pre-op holding area. Visible tumor and prior tumor sites will be targeted for tissue sampling (no more than two sites will be targeted). A standardized tumor quantification system will be employed to document location and presence of tumor and previous biopsy sites. To this end, the investigators have developed a novel scoring system that allows for objective quantification of endoscopic findings at the time of cystoscopy and indexes presence and location of papillary tumor, erythema, and scar. Two additional random biopsies will be obtained, one from the posterior wall and one from the lateral wall for assessment of genomic signatures within normal-appearing mucosa.
Tumor location and its relationship to the ureteral orifices will be noted in order to assist the surgeon in performance of radical cystectomy. The patient will then undergo radical cystectomy as per standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Reliability of Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder at the Time of Radical Cystectomy|
|Actual Study Start Date :||November 11, 2016|
|Actual Primary Completion Date :||August 19, 2019|
|Estimated Study Completion Date :||April 1, 2027|
Procedure: Radical Cystectomy
- To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy. [ Time Frame: 30 days post surgery ]Endoscopic assessments will be performed using a novel scoring system that allows objective quantification of endoscopic findings at the time of cystoscopy. The findings will be compared to final pathological specimen to determine reliability of predicting pTO disease from endoscopic assessment
- To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response. [ Time Frame: up to 5years post surgery ]Archival specimen of prior diagnostic TUR will be prepared as 10-20 unstained 5-10 micron slides to under-go next generation sequencing and be compared to final cystectomy specimen to investigate potential pre-treatment signatures predictive of response to chemotherapy. Chemotherapy response will be measured by pathological assessment of residual tumor at cystectomy and graded by TNM staging criteria.
- To determine how genomic tumor signatures compare before and after chemotherapy administration. [ Time Frame: up to 5years post surgery ]Archival specimen of prior diagnostic TUR will be prepared as 10-20 unstained 5-10 micron slides to under-go next generation sequencing and be compared to final cystectomy specimen to determine genomic signatures before and after chemotherapy.
- To determine if genomic signature from tissue obtained on endoscopic evaluation just prior to cystectomy can help predict final pathological stage. [ Time Frame: up to 5years post surgery ]Comparison of baseline archival tumor tissue and final specimen will be compared for whether viable tumor tissue remains at time of surgery, for changes in total number of mutations found, whether specific mutations evolve from before to after chemo, and whether a pre-treatment genomic signature is predictive of chemo response. Specifically, DNA will be isolated from pre- and post- chemotherapy urine samples and subjected to targeted deep sequencing to support the hypothesis that mutation clearance correlates with pathologic response in the radical cystectomy specimen. These studies will provide orthogonal validation and could prove more sensitive than pathological analysis. In addition, they may serve as further basis for highly stringent selection of complete responders in whom cystectomy could be avoided in the future.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968732
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Alexander Kutikov, MD||Fox Chase Cancer Center|