Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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