Urothelial CarcinomaINSITENCT06396533
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
An observational study of Urothelial Carcinoma and Muscle Invasive Bladder Urothelial Carcinoma, run by Fox Chase Cancer Center at 2 sites in United States.
Trial summary
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Urothelial Carcinoma
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2024to 23 Feb 2029
- Phase
- Observational
- 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
Study population: Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria. Eligible patients will have bio specimen collected in accordance with the trial protocol.
Who may be able to join
- Properly counselled patients with high grade T1 disease who elect for cystectomy
- Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
- cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
- Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
- Male or female patients age >=18 years at the time of consent.
- Able and willing to comply with study requirements.
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- Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process.
- Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
- Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.
Who cannot join
- Patients who undergo cystectomy with non-curative intent will be excluded.
- Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
- Patients who are pregnant or nursing.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Jared Schober, MD
Jared Schober, MD
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Alexander Kutikov, M.D., 215-728-3096, alexander.kutikov@fccc.edu
About this study
Official title: Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
Read the detailed description
The principle outcome of this study is to determine the negative predictive value (NPV) of finding no muscle invasive (pT2) tumor in seeT0 patients with a negative result on the ctDNA assay prior to radical cystectomy.
Eligible candidates for radical cystectomy and INSITE trial:
- Patients with high grade T1 urothelial carcinoma who elect for "early" /upfront cystectomy
- Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who have relapsed or are refractory / unresponsive to intravesical therapy and have elected to undergo cystectomy
- cT2-T3 muscle invasive urothelial carcinoma (irrespective of receipt of neo-adjuvant chemotherapy) Prior to cystectomy, tissue (transurethral resection of bladder tumor), urine and blood samples will be obtained at baseline for urine biopsy, ctDNA testing and future correlative studies.
After anesthetic induction for radical cystectomy, the patient will undergo rigid cystoscopy with targeted transurethral resection (TUR) of visible tumor or tumor bed, and two additional random bladder biopsies of normal-appearing bladder mucosa. Urine and blood samples will be obtained day of procedure for utilization for urine biopsy, ctDNA, and future correlative studies.
Following cystectomy, a diagnostic testing panel of pre-cystectomy cystoscopic and biopsy findings, ctDNA, and urine biopsy will be compared to final pathologic specimen.
Blood samples will be obtained 4-6 weeks (±2 weeks) post-procedure and 6 months (±1 month) post-procedure for analysis and ctDNA for post-procedure surveillance and other additional correlative studies. Additional blood sample collections at 12 months and 24 months post-procedure are optional.
- Conditions
- Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Urothelial Carcinoma
- Keywords
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Non- neoadjuvant chemotherapy patients | Archival (FFPE) specimen of prior diagnostic TUR will be obtained. For patients receiving neoadjuvant chemotherapy: Blood will be collected at pre-treatment/baseline, mid-treatment(C3D1), day of cystectomy, and then only serum/plasma 4-6 weeks (±2 weeks) post-cystectomy, and 6 months (±1 month) post-cystectomy. For patients not receiving neoadjuvant chemotherapy: Freshly voided mid-stream urine will be collected on the day of cystectomy. | |
| Neoadjuvant Chemotherapy (NAC) Patients | Archival (FFPE) specimen of prior diagnostic TUR will be obtained. For patients not receiving neoadjuvant chemotherapy: Serum/plasma will be collected on the day of cystectomy, and only serum/plasma 4-6 weeks (±2 weeks) post-cystectomy, and 6 months (±1 month) post-cystectomy. For patients receiving neoadjuvant chemotherapy: Freshly voided mid-stream urine will be collected from each subject at pre-treatment, mid-treatment (C3D1), and the day of cystectomy. Stool samples will be collected in OMNIgene GUT kits. Patients who are not undergoing NAC, will be provided one kit for stool collection prior to cystectomy at baseline. All stool samples will be sent to Case Western Microbiome Core for analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence
Determine the utility of a novel, proprietary combined blood and urinary genomic biomarker (ctDNA and cfDNA) assay in predicting the presence or absence of a muscle-invasive bladder cancer at cystectomy when no disease is identified on systematic endoscopic evaluation (SEE, aka seeT0).
Measured: 2 years
Utility of a DNA test for muscle-invasive bladder cancer presence
Negative predictive value (NPV) of a negative ctDNA and urine-based cfDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy with a pre-surgical seeT0 bladder.
Measured: 2 years
Secondary outcomes (2)
Accuracy of surgical specimen DNA test to predict muscle-invasive disease
Determine the accuracy of a negative blood-based ctDNA assay combined with a urinary genomic cfDNA assay to predict the presence or absence of muscle-invasive disease in cystectomy surgical specimen.
Measured: 2 years
Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence
Negative predictive value (NPV) of blood-based ctDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start13 Aug 2024
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Alexander Kutikov, M.D., Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396533
- Sponsor's protocol ID
- GU-222, 24-4001
- Acronym
- INSITE
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
- ClinicalTrials.gov ID
- NCT06396533
- Acronym / sponsor ID
- INSITE / GU-222, 24-4001
- Conditions
- Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Urothelial Carcinoma
- Keywords
- cystectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Feb 2029 (estimated)
- First posted
- 2 May 2024 (actual)
- 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.
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
Detailed description
The principle outcome of this study is to determine the negative predictive value (NPV) of finding no muscle invasive (pT2) tumor in seeT0 patients with a negative result on the ctDNA assay prior to radical cystectomy.
Eligible candidates for radical cystectomy and INSITE trial:
- Patients with high grade T1 urothelial carcinoma who elect for "early" /upfront cystectomy
- Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who have relapsed or are refractory / unresponsive to intravesical therapy and have elected to undergo cystectomy
- cT2-T3 muscle invasive urothelial carcinoma (irrespective of receipt of neo-adjuvant chemotherapy) Prior to cystectomy, tissue (transurethral resection of bladder tumor), urine and blood samples will be obtained at baseline for urine biopsy, ctDNA testing and future correlative studies.
After anesthetic induction for radical cystectomy, the patient will undergo rigid cystoscopy with targeted transurethral resection (TUR) of visible tumor or tumor bed, and two additional random bladder biopsies of normal-appearing bladder mucosa. Urine and blood samples will be obtained day of procedure for utilization for urine biopsy, ctDNA, and future correlative studies.
Following cystectomy, a diagnostic testing panel of pre-cystectomy cystoscopic and biopsy findings, ctDNA, and urine biopsy will be compared to final pathologic specimen.
Blood samples will be obtained 4-6 weeks (±2 weeks) post-procedure and 6 months (±1 month) post-procedure for analysis and ctDNA for post-procedure surveillance and other additional correlative studies. Additional blood sample collections at 12 months and 24 months post-procedure are optional.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non- neoadjuvant chemotherapy patients | – | –Archival (FFPE) specimen of prior diagnostic TUR will be obtained. For patients receiving neoadjuvant chemotherapy: Blood will be collected at pre-treatment/baseline, mid-treatment(C3D1), day of cystectomy, and then only serum/plasma 4-6 weeks (±2 weeks) post-cystectomy, and 6 months (±1 month) post-cystectomy. For patients not receiving neoadjuvant chemotherapy: Freshly voided mid-stream urine will be collected on the day of cystectomy. |
| Neoadjuvant Chemotherapy (NAC) Patients | – | –Archival (FFPE) specimen of prior diagnostic TUR will be obtained. For patients not receiving neoadjuvant chemotherapy: Serum/plasma will be collected on the day of cystectomy, and only serum/plasma 4-6 weeks (±2 weeks) post-cystectomy, and 6 months (±1 month) post-cystectomy. For patients receiving neoadjuvant chemotherapy: Freshly voided mid-stream urine will be collected from each subject at pre-treatment, mid-treatment (C3D1), and the day of cystectomy. Stool samples will be collected in OMNIgene GUT kits. Patients who are not undergoing NAC, will be provided one kit for stool collection prior to cystectomy at baseline. All stool samples will be sent to Case Western Microbiome Core for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria. Eligible patients will have bio specimen collected in accordance with the trial protocol.
Key inclusion criteria (9 listed)
- Properly counselled patients with high grade T1 disease who elect for cystectomy
- Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
- cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
- Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
- Male or female patients age >=18 years at the time of consent.
Key exclusion criteria (3 listed)
- Patients who undergo cystectomy with non-curative intent will be excluded.
- Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
- Patients who are pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence
Time frame: 2 years
Determine the utility of a novel, proprietary combined blood and urinary genomic biomarker (ctDNA and cfDNA) assay in predicting the presence or absence of a muscle-invasive bladder cancer at cystectomy when no disease is identified on systematic endoscopic evaluation (SEE, aka seeT0).
Utility of a DNA test for muscle-invasive bladder cancer presence
Time frame: 2 years
Negative predictive value (NPV) of a negative ctDNA and urine-based cfDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy with a pre-surgical seeT0 bladder.
2 secondary outcomes
Accuracy of surgical specimen DNA test to predict muscle-invasive disease
Time frame: 2 years
Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence
Time frame: 2 years
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 2 Nov 2026.
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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.
Alexander Kutikov, M.D. principal investigator
Fox Chase Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Muscle Invasive Bladder Urothelial Carcinoma, run by Fox Chase Cancer Center at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Alexander Kutikov, M.D. (215-728-3096, alexander.kutikov@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.