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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 : April 15, 2020
Sponsor:
Collaborator:
Temple University
Information provided by (Responsible Party):
Fox Chase Cancer Center

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 21, 2016
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE November 11, 2016
Actual Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder
Official Title  ICMJE Assessment of Reliability of Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder at the Time of Radical Cystectomy
Brief Summary A prospective, investigational study to assess the accuracy of standardized cystoscopic evaluation with tissue sampling performed immediately prior to definitive radical cystectomy to predict pathologic tumor stage and identify patients who may benefit from bladder preservation therapy.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE Procedure: Radical Cystectomy
Study Arms  ICMJE Experimental: Surgical
Intervention: Procedure: Radical Cystectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 14, 2020)
65
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
80
Estimated Study Completion Date  ICMJE April 1, 2027
Actual Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients age >18 years at the time of consent.
  2. Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0.
  3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
  4. Patients must have a clinical decision to proceed with radical cystectomy by any conventional approach (open, laparoscopic, robot-assisted laparoscopic). Time from decision to surgery is usually 3-8 weeks for those who do not receive neoadjuvant chemotherapy and 10-14 weeks for those who receive neo-adjuvant chemotherapy treatment. During this time, eligibility for study participation will be verified.
  5. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document or a legally authorized representative who has the ability to understand and willingness to sign a written informed consent and HIPAA authorization on behalf of the participant.
  6. Women of reproductive potential must have agreed to use an effective contraceptive measure.

Exclusion Criteria:

  1. Patients who undergo cystectomy with non-curative intent will be excluded.
  2. Patients who have undergone any prior pelvic irradiation.
  3. Patients who are pregnant or nursing. Radical cystectomy and prolonged general anesthesia would place the fetus at considerable risk of demise. The prolonged recovery and debility of the patient would severely limit the patient's ability to nurse and care for an infant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02968732
Other Study ID Numbers  ICMJE GU-095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fox Chase Cancer Center
Study Sponsor  ICMJE Fox Chase Cancer Center
Collaborators  ICMJE Temple University
Investigators  ICMJE
Principal Investigator: Alexander Kutikov, MD Fox Chase Cancer Center
PRS Account Fox Chase Cancer Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP