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

Description

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.

Conditions

Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Urothelial Carcinoma

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Urothelial Carcinoma
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Properly counselled patients with high grade T1 disease who elect for cystectomy
  • 2. 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
  • 3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
  • 4. 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).
  • 5. Male or female patients age \>=18 years at the time of consent.
  • 6. Able and willing to comply with study requirements.
  • 7. 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.
  • 8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
  • 9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.
  • 1. Patients who undergo cystectomy with non-curative intent will be excluded.
  • 2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
  • 3. Patients who are pregnant or nursing.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fox Chase Cancer Center,

Alexander Kutikov, M.D., PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

2029-02-23