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 a recurrence of bladder cancer.
- Patient has undergone any prior radiation therapy (including brachytherapy therapy) to target lesion prior to surgery.
- Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to surgery.
Inclusion Criteria - Control Tissue:
- Patient is undergoing prostatectomy.
- Age ≥ 18 years.
Exclusion Criteria - Control Tissue:
- Patient has undergone any prior radiation therapy (including brachytherapy therapy) to the bladder prior to surgery.
- Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to surgery.
- Patient has had bladder, urothelial or kidney cancer
Inclusion Criteria - Control Buffy:
Exclusion Criteria - Control Buffy:
- Patient has known primary cancer within the last 5 years prior blood collection (not including basal cell or squamous cell skin cancers).
- Patient has undergone prior radiation therapy in the 5 years prior to blood collection.
- Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to blood collection.
Inclusion Criteria - Case Urine:
Cases will be enrolled from a cohort of patients undergoing diagnostic evaluation and treatment for bladder cancer collected under IRB 21-009854 (PI: Kisiel).
- Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.
- Age ≥ 18 years
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.
- Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection.
- Patient a has chronic indwelling urinary catheter.
- Patient has had a urinary tract infection within the 14 days prior to sample collection.
Inclusion Criteria - Disease Control Urine:
- Patient has history of non-muscle invasive bladder cancer and negative surveillance cystoscopy.
- Age ≥ 18 years.
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.
- Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection.
- Patient a has chronic indwelling urinary catheter.
- Patient has had a urinary tract infection within the 14 days prior to sample collection.
Inclusion Criteria - Healthy Control Urine:
Exclusion Criteria - Healthy Control Urine:
- 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.
- Patient has chronic indwelling urinary catheter.
- Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to sample collection.
- Patient has had a urinary tract infection within 14 days prior to urine collection.
Inclusion Criteria - Case Blood:
Cases will be enrolled from a cohort of patients undergoing diagnostic evaluation and treatment for bladder cancer collected under IRB 21-009854 (PI: Kisiel).
- Patient has a histological diagnosis of invasive urothelial cell carcinoma of bladder..
- Age ≥ 18 years.
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 bladder cancer.
- Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
- Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
- Patient has received chemotherapy class drugs for the treatment of 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.
Inclusion Criteria - Disease Control Blood (Case patients with non-muscle invasive bladder cancer):
- Patient has history of non-muscle invasive bladder cancer and negative surveillance cystoscopy.
- Age ≥ 18 years.
Exclusion Criteria - Disease Control Blood (Case patients with non-muscle invasive bladder cancer):
- 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 bladder cancer.
- Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
- Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
- Patient has received chemotherapy class drugs for the treatment of 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.
Inclusion Criteria - Healthy Control Blood:
Exclusion Criteria - Healthy Control 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/27/2024. Questions regarding updates should be directed to the study team contact