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Trial Title:
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay
NCT ID:
NCT05643690
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Observational
Overall status:
Suspended
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
UriFind Bladder Cancer Assay
Description:
The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation
biomarkers in urine specimens from patients 22 years or older suspected of having bladder
cancer. Results from the Assay are intended for use, in conjunction with current standard
diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.
Arm group label:
Clinical Validation Group
Summary:
The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation
biomarkers in urine specimens from patients 22 years or older suspected of having bladder
cancer. Results from the assay are intended for use, in conjunction with current standard
diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.
Criteria for eligibility:
Study pop:
The clinical validation group is to assess the safety and effectiveness of the AnchorDx
UriFind™ Bladder Cancer Assay in an intended use population to establish the expected
performance in the product labeling. The study also aims to provide performance evidence
of the AnchorDx UriFind™ Bladder Cancer Assay in adequate number of early-stage and
low-grade cases.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Clinical Validation Group:
1. 55 years or older, gender is not limited
2. Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral
resection of bladder tumor (TUBRT)
3. Can receive standard of care, including urine cytology, cystoscopy, or surgery for
bladder cancer diagnosis
4. Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)
Exclusion Criteria:
1. History of urinary cancer
2. Neoadjuvant therapy
Gender:
All
Minimum age:
55 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Arkansas Urology
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Facility:
Name:
Idaho Urologic Institute
Address:
City:
Meridian
Zip:
83642
Country:
United States
Start date:
November 18, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
AnchorDx Medical Co. Ltd. US
Agency class:
Industry
Collaborator:
Agency:
AnchorDx Medical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Specialty Networks
Agency class:
Other
Source:
AnchorDx Medical Co. Ltd. US
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05643690
