Bladder CancerNCT05643690

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

An observational study of Bladder Cancer, run by AnchorDx Medical Co. Ltd. US at 2 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 55 to 100 years
Conditions the study is for: Bladder Cancer
What is being tested?: UriFind Bladder Cancer Assay
How many people: 77 participants
Where: 2 sitesUnited States
Study dates: 18 Nov 2022to 31 Dec 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Clinical Validation Group:
55 years or older, gender is not limited
Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT)
Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)

Who cannot join

History of urinary cancer
Neoadjuvant therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Arkansas Urology
Little Rock, Arkansas, 72211
Idaho Urologic Institute
Meridian, Idaho, 83642

Other trials in United States

About this study

Official title: Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay in Subjects Suspected of Having Bladder Cancer

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.

Conditions: Bladder Cancer
Being tested: UriFind Bladder Cancer Assay
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UriFind Bladder Cancer AssayDiagnostic test
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.

Study groups in NCT05643690
Study group	Role	What they receive
Clinical Validation Group		Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results) Receives: Diagnostic Test: UriFind Bladder Cancer Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer
To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202231 Dec 2025

First posted9 Dec 2022
Study start18 Nov 2022
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Why it stopped: Protocol amendment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bladder CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05643690
Sponsor's protocol ID: UriFind US-001
Status last verified: Jun 2024
First submitted: 14 Nov 2022
Last updated: 6 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay in Subjects Suspected of Having Bladder Cancer
ClinicalTrials.gov ID: NCT05643690
Acronym / sponsor ID: UriFind US-001
Conditions: Bladder Cancer
Study type: Observational
Recruitment status: SuspendedReason stopped: Protocol amendment.
Enrolment: 77 participants (actual)
Lead sponsor: AnchorDx Medical Co. Ltd. USIndustry (pharma, biotech, devices)
Collaborators: AnchorDx Medical Co., Ltd., Specialty Networks
Study start: 18 Nov 2022 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 9 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Clinical Validation Group	–	Diagnostic Test: UriFind Bladder Cancer AssayPatients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)

Who may qualify

Ages: 55 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (5 listed)

55 years or older, gender is not limited
Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT)
Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)

Key exclusion criteria (2 listed)

History of urinary cancer
Neoadjuvant therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UriFind Bladder Cancer AssayThe 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.	Diagnostic test	Clinical Validation Group

Primary outcome

Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer
Time frame: Baseline
To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
Individual participant dataSharing planned: No

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianbing Fan, Ph.D study director

AnchorDx Medical Co., Ltd.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by AnchorDx Medical Co. Ltd. US at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05643690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.