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

NCT06396533 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2025-10-31

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY
  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Alexander Kutikov, M.D. · Fox Chase Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2027-04-23
Completion
2029-02-23

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06396533 on ClinicalTrials.gov