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NCT06396533Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
92 (estimated)
First submitted
27 Mar 2024
Start date
13 Aug 2024
Primary completion date
23 Apr 2027
Lead sponsor
Fox Chase Cancer Center
NCT number
NCT06396533

What you commit to

  • Study type: Observational
  • Planned participants: 92
  • From 13 Aug 2024 to the primary completion date, 23 Apr 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.

Other

  • Patients who undergo cystectomy with non-curative intent will be excluded.
  • Patients who are pregnant or nursing.

Who the study is looking for

  • 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.