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Trial Title:
Bladder Bank (a Prospective Banking Study)
NCT ID:
NCT06109857
Condition:
Bladder Carcinoma
Hematuria
Conditions: Official terms:
Urinary Bladder Neoplasms
Hematuria
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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.
Criteria for eligibility:
Study pop:
Patient has undergone office-based evaluation for hematuria
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
John B. Kisiel, MD
Start date:
July 6, 2022
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109857
https://www.mayo.edu/research/clinical-trials
