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.
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
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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||November 11, 2016||N/A||Interventional|
Primary Outcome 1 - Measure: To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.
Primary Outcome 1 - Time Frame: 30 days post surgery
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
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
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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Alexander Kutikov, MD
Role: Principal Investigator
Affiliation: Fox Chase Cancer Center