Clinical trial · Observational
A Diagnostic for the Early Detection of Bladder Cancer
A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer
NCT05347342CI-TRIAL-00102254active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- 1. To assess the ability to recruit and retain an appropriate high-risk group of subjects into a 4-year longitudinal study monitoring them for the development of bladder cancer.
- timeFrame
- 5 years
- description
- Ability to recruit
- measure
- 2. To report the sensitivity and specificity of the multiplex immunoassay ability to detect bladder cancer in patients with high risk of developing bladder cancer: >50 years and >40 pack year history of tobacco exposure.
- timeFrame
- 5 years
- description
- Performance of multiplex test in this study
- measure
- 3. To develop a prediction risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.
- timeFrame
- 5 years
- description
- Development of a risk calculator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.