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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06109857
Other study ID # 21-009854
Secondary ID NCI-2023-0064421
Status Recruiting
Phase
First received
Last updated
Start date July 6, 2022
Est. completion date December 1, 2025

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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 - Patient has prior diagnosis of bladder cancer for which prior resection of tumor was performed

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-Interventional Study
Non-interventional study

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood sample to support the development of non-invasive tests for early detection of bladder cancer 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. Baseline (at enrollment)
Primary Urine sample to support the development of non-invasive tests for early detection of bladder cancer 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. Baseline (at enrollment)
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