A Diagnostic for the Early Detection of Bladder Cancer

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

ACTIVE_NOT_RECRUITING

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-29

Study Completion Date

2029-01-31

Brief Summary

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

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

Related Clinical Trials

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

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

NCT03193541

Bladder Cancer

RECRUITING

Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder

NCT02745301

Bladder Cancer, Biomarkers

COMPLETED

Predicting BCG Response

NCT04564781

Bladder Cancer

RECRUITING

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

NCT03193515

Bladder Cancer

RECRUITING

Prognostic Biomarkers in Patients With Urothelial Carcinoma

NCT04872036

Bladder Cancer

COMPLETED

Detailed Description

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

Environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. To date, there are no diagnostics capable of detecting bladder cancer early, that is prior to clinical presentation. Because of this severe limitation, nearly 30% of patients initially present with stage 2 and higher bladder cancer. Stage 2 bladder cancer has a 5-year survival of 50%, while stage 3/4 have a 5-year survival of \<20%. Ideally, bladder cancer would be preventable. Unfortunate, this has not come to fruition. If these stage 2-4 bladder cancer cases could be detected at Stage 1 (5-yr survival \>94%), then its possible to see an improvement in bladder cancer survival rates (21-23).

in this study, a urine-based diagnostic that possesses the potential to accurately identify patients who harbor bladder cancer prior to clinical manifestation will be tested.

Conditions

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

Bladder Cancer

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

Eligibility Criteria

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

Inclusion Criteria

Participants must be:

1. Age 50 years or older
2. \>20 pack year history of tobacco exposure
3. Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
5. Willing and able to give written informed consent
6. Willing to provide voided urine sample
7. Be able and willing to complete semi-annual research clinic visits for 4 years

Exclusion Criteria

Participants must not have:

1. History of hematuria (microscopic or gross) within 2 years of signing consent.
2. Previous history of bladder cancer
3. A known active urinary tract infection or urinary retention
4. An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.
5. An ureteral stents, nephrostomy tubes or bowel interposition
6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes