Urothelial CarcinomaNCT02968732
Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder
A study testing Radical Cystectomy in people with Urothelial Carcinoma, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Radical Cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2016to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients age >18 years at the time of consent.
- Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- 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.
- 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.
- Women of reproductive potential must have agreed to use an effective contraceptive measure.
Who cannot join
- Patients who undergo cystectomy with non-curative intent will be excluded.
- Patients who have undergone any prior pelvic irradiation.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Assessment of Reliability of Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder at the Time of Radical Cystectomy
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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- Radical Cystectomy
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical CystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Experimental | Not described Receives: Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.
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
Measured: 30 days post surgery
Secondary outcomes (3)
To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response.
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.
Measured: up to 5years post surgery
To determine how genomic tumor signatures compare before and after chemotherapy administration.
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.
Measured: up to 5years post surgery
To determine if genomic signature from tissue obtained on endoscopic evaluation just prior to cystectomy can help predict final pathological stage.
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.
Measured: up to 5years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start11 Nov 2016
- Primary completion19 Aug 2019
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Sponsor
- Investigators
- Alexander Kutikov, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968732
- Sponsor's protocol ID
- GU-095
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2016
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Satyal U, Valentine H, Liu D, Slifker M, Lallas CD, Trabulsi EJ, Bukavina L, Szeto L, Hoffman-Censits JH, Mouw KW, Faltas BM, Grivas P, Ibragimova I, Porten SP, Van Allen EM, Geynisman DM, Parker DC, O'Neill JP, Drevik J, Christianson SS, Ginzburg S, Correa AF, Uzzo RG, Ross EA, Zibelman MR, Ghatalia P, Plimack ER, Kutikov A, Abbosh PH. Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates. JCO Precis Oncol. 2024 Jun;8:e2300362. doi: 10.1200/PO.23.00362.
PubMed 38865671
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reliability of Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder at the Time of Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02968732
- Acronym / sponsor ID
- GU-095
- Conditions
- Urothelial Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | Experimental | Procedure: Radical Cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients age >18 years at the time of consent.
- Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- 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.
- 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.
Key exclusion criteria (3 listed)
- Patients who undergo cystectomy with non-curative intent will be excluded.
- Patients who have undergone any prior pelvic irradiation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical Cystectomy | Procedure or surgery | Surgical |
Primary outcome
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
3 secondary outcomes
To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response.
Time frame: up to 5years post surgery
To determine how genomic tumor signatures compare before and after chemotherapy administration.
Time frame: up to 5years post surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 38865671Satyal U, Valentine H, Liu D, Slifker M, Lallas CD, Trabulsi EJ, Bukavina L, Szeto L, Hoffman-Censits JH, Mouw KW, Faltas BM, Grivas P, Ibragimova I, Porten SP, Van Allen EM, Geynisman DM, Parker DC, O'Neill JP, Drevik J, Christianson SS, Ginzburg S, Correa AF, Uzzo RG, Ross EA, Zibelman MR, Ghatalia P, Plimack ER, Kutikov A, Abbosh PH. Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates. JCO Precis Oncol. 2024 Jun;8:e2300362. doi: 10.1200/PO.23.00362.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Kutikov, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Cystectomy in people with Urothelial Carcinoma, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.