Bladder Carcinoma
Conditions
Brief summary
This study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.
Detailed description
PRIMARY OBJECTIVE: I. To establish a biobank of samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer. OUTLINE: This is an observational study. Patients undergo blood and urine sample collection and have their medical records reviewed while on study.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Patient has undergone office-based evaluation for hematuria \[computed tomography (CT), ultrasound, cystoscopy\]
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood sample to support the development of non-invasive tests for early detection of bladder cancer | Baseline (at enrollment) | At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and processed according to standardized study biospecimen protocol. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic. |
| Urine sample to support the development of non-invasive tests for early detection of bladder cancer | Baseline (at enrollment) | At study enrollment for subjects, up to 20mL of urine will be collected from the same or unique case patients identified for blood collection. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORJohn B. Kisiel, MD
Mayo Clinic in Rochester
Outcome results
None listed