Blood And Urine Identification Of Methylated DNA Markers In Invasive Bladder Carcinoma

Overview

About this study

The purpose of this study is to, in tissue, discover and validate DNA methylation markers (MDMs) for detection of invasive urothelial carcinoma of the bladder. In blood, to assess the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. In urine, to explore the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder.  Diagnostic accuracy on urine can be compared with that on plasma using paired samples.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Case Tissue:

  • Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.

  • Age ≥ 18 years.

Exclusion Criteria - Case Tissue:

  • Patient has received cancer treatment in the 5 years prior to TURBT/CBF.

  • Patient has had any prior radiation therapy (including brachytherapy therapy) to the target lesion prior to TURBT/CBF

  • Patient has a recurrent muscle invasive bladder cancer.

Exclusion – Cystectomy/Cystoprostatectomy

  • Patient has received cancer treatment in the 5 years prior to Cystectomy/Cystoprostatectomy.

  • Patient has had any prior radiation therapy (including brachytherapy therapy) to the target lesion prior to Cystectomy/Cystoprostatectomy.

  • Patient has a recurrent muscle invasive bladder cancer

Inclusion Criteria Control Tissue:

  • Patient is undergoing prostatectomy.  

  • Age ≥ 18 years.

Exclusion Criteria - Control Tissue:

  • Patient has received cancer treatment in the 5 years prior to Prostatectomy.

    Patient has had any prior radiation therapy (including brachytherapy therapy) to the target tissue prior to Prostatectomy.

  • Patient has had bladder, urothelial or kidney cancer

Inclusion Criteria - Blood:

  • Age ≥ 18 years.

Exclusion Criteria - Blood:

  • Patient has had a past or current diagnosis of invasive cancer  (this does not include basal or squamous skin cancers.

  • Patient has had a solid organ transplant.

Inclusion Criteria - Case Urine:

  • Age >18 years.

  • Patient has undergone office-based evaluation for hematuria (CT, ultrasound, cystoscopy)

  • Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.

Exclusion Criteria - Case Urine:

  • ·Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)

    Patient has recurrent muscle invasive bladder cancer.

    Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.

    Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection.

    Patient has had any prior radiation therapy to the target lesion prior to current collection.

    Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.

    Patient has undergone cystectomy or cystoprostatectomy.

    Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection.

    Patient has had a urinary tract infection within 14 days prior to urine collection.

    Patient has chronic indwelling urinary catheter.

Inclusion Criteria - Disease Control Urine:

  • Age >18 years.

  • Patient has undergone office-based evaluation for hematuria (CT, ultrasound, cystoscopy)                                                

Exclusion Criteria - Disease Control Urine:

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible.

  • Patient has recurrent muscle invasive bladder cancer.

  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.

  • Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection.

  • Patient has had any prior radiation therapy to the target lesion prior to current collection.

  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.

  • Patient has undergone cystectomy or cystoprostatectomy.

  • Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection.

  • Patient has had a urinary tract infection within 14 days prior to urine collection.

  • Patient has chronic indwelling urinary catheter .

Inclusion Criteria - Case Blood:

  • Age >18 years.

  • Patient has undergone office-based evaluation for hematuria (CT, ultrasound, cystoscopy)

  • Patient has a histological diagnosis of invasive urothelial cell carcinoma of bladder.

Exclusion Criteria - Case Blood:

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible.

  • Patient has recurrent muscle invasive bladder cancer.

  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.

  • Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection.

  • Patient has had any prior radiation therapy to the target lesion prior to current collection.

  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.

  • Patient has undergone cystectomy or cystoprostatectomy.

Inclusion Criteria - Disease Control Blood

  • Patient has undergone office-based evaluation for hematuria (CT, ultrasound, cystoscopy)

  • Age ≥ 18 years.                                     

Exclusion Criteria - Disease Control Blood

  • ·Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)

  • Patient has recurrent muscle invasive bladder cancer.

  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.

  • Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection.

  • Patient has had any prior radiation therapy to the target lesion prior to current collection.

  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.

  • Patient has undergone cystectomy or cystoprostatectomy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/4/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Open for enrollment

Contact information:

Anna Gonser M.S., CCRP

(507) 538-4883

Gonser.Anna@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20544125

Mayo Clinic Footer