Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer

• Sponsor: Nucleix Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06020807
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 40.9

Study Details

Study Description

Brief Summary

This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.

Condition or Disease	Intervention/Treatment	Phase
Non Muscle Invasive Bladder Cancer; Non-Muscle Invasive Bladder Urothelial Carcinoma	Diagnostic Test: Bladder EpiCheck

Study Design

• Study Type: Observational
• Actual Enrollment: 168 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
• Actual Study Start Date: Sep 5, 2019
• Actual Primary Completion Date: Jan 8, 2020
• Actual Study Completion Date: Jan 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Healthy Healthy subjects and urology patients without prior history or evidence of bladder cancer	Diagnostic Test: Bladder EpiCheck; Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.

Outcome Measures

Primary Outcome Measures

1. Specificity [Day 1]

   The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 22 or older

• Able to sign the informed consent form

• Normal, healthy subjects or subjects with one of the following conditions:

1. Benign non-genitourinary disease (e.g. heart disease)

2. Non-genitourinary cancers (e.g. lung, CRC, breast)

3. Genitourinary disease other than bladder cancer including:

4. Benign prostatic hyperplasia (BPH)

5. Microhematuria proven negative for bladder cancer through prior UCC evaluation

6. Inflammation/infection

7. Symptomatic sexually transmitted disease (STD)

8. Urinary tract stones

9. Genitourinary trauma

• Subjects with native bladder

Exclusion Criteria:

• Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)

• Currently in work-up due to suspicion of cancer of any kind

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Nucleix Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nucleix Ltd.
• ClinicalTrials.gov Identifier: NCT06020807
• Other Study ID Numbers: UC-Bladder EpiCheck-FDA-02
• First Posted: Sep 1, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Study Results

No Results Posted as of Sep 7, 2023