Brief Title
Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder
Official Title
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
Interventional
Primary Outcome
To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.
Secondary Outcome
To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response.
Condition
Urothelial Carcinoma
Intervention
Radical Cystectomy
Study Arms / Comparison Groups
Surgical
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
65
Start Date
November 11, 2016
Completion Date
April 1, 2027
Primary Completion Date
August 19, 2019
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alexander Kutikov, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02968732
Organization ID
GU-095
Responsible Party
Sponsor
Study Sponsor
Fox Chase Cancer Center
Collaborators
Temple University
Study Sponsor
Alexander Kutikov, MD, Principal Investigator, Fox Chase Cancer Center
Verification Date
May 2022