Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay

AnchorDx Medical Co. Ltd. US

Status: Suspended

Conditions: Bladder Cancer

Treatments: Diagnostic Test: UriFind Bladder Cancer Assay

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05643690

UriFind US-001

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

77 participants in 1 patient group

Clinical Validation Group

Description:

Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)

Treatment:

Diagnostic Test: UriFind Bladder Cancer Assay