RECRUITING

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

Conditions

Urothelial Carcinoma Muscle Invasive Bladder Urothelial Carcinoma Non-Muscle Invasive Bladder Urothelial Carcinoma cystectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-13

Study Completion:2029-02-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06396533

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Alexander Kutikov, M.D.

CONTACT

215-728-3096

alexander.kutikov@fccc.edu

Principal Investigator

Alexander Kutikov, M.D.

PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13

Study Completion Date2029-02-23

Study Record Updates

Study Start Date2024-08-13

Study Completion Date2029-02-23

Terms related to this study

Keywords Provided by Researchers

cystectomy

Additional Relevant MeSH Terms

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