Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

92 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Fox Chase Cancer Center

Lead sponsor

Janssen Pharmaceuticals

Collaborator