Detecting Transitional Cell Carcinoma From Haematuria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-18

Study Completion Date

2019-05-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Detecting Bladder Cancer Using the UroMark Test.

NCT02676180

Bladder Cancer

COMPLETED

To Detect the Sensitivity of the UroMark Assay

NCT02781428

Bladder Cancer

COMPLETED

The Cxbladder Monitoring Study

NCT02700659

Urothelial Carcinoma

COMPLETED

A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

NCT03193541

Bladder Cancer

RECRUITING

Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer:

NCT03548688

Urothelial Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC early is crucial to increase the chances of a cure. Cystoscopy, which is currently the standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive procedure but, while several potential markers in urine have been studied with the goal of replacing cystoscopy, no urinary marker alone or in combination with others has shown sufficient accuracy.

In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine samples collected from patients referred to the haematuria clinic with visible or microscopic haematuria. These values will be linked to the subsequent diagnosis of each patient, and used to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transitional Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All participants

Patients with haematuria.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Capable of giving written informed consent
* Age ≥18 years
* Referral to haematuria clinic (gross or microscopic haematuria)

Exclusion Criteria

* Inability to provide written informed consent
* Previous radiotherapy to the bladder (e.g. prostate cancer)
* Active urinary tract infection (Patients may be re-approached at later opportunity when urinary infection is cleared and haematuria persists)
* Current or planned treatment with neoadjuvant chemotherapy or radiotherapy
* Other known malignant condition, either active or in complete remission ≤5 years
* HIV, hepatitis C, or any other known communicable disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No