Clinical trial · Observational
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as a Tool for Early Diagnosis, Non-invasive Monitoring and Prediction of Recurrence Risk in Bladder Cancer
- 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)
Multicenter, observational, prospective, biological pilot study on liquid biopsy, aimed at investigating methylation profiles in relation to the early diagnosis of bladder cancer, to validate the potential of commercially available tests (e.g. BladderCARE, Bladder EpiCheck), to apply and validate tests based on targeted multi-marker or genome wide analyzes via NGS and to identify methylation profiles as a tool to infer clinical outcome.
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
Design
Arms and outcomes
Arms (2)
- label
- Patients suffering from bladder cancer
- description
- Patients with a proven diagnosis of muscle-infiltrating or non-muscle-infiltrating bladder cancer, having performance status (PS) 0-1.
- label
- Healthy persons.
- description
- Healthy persons with no previous or current medical history associated with bladder cancer or diagnostic suspicion associated with cancer, to be used as a relative reference.
Primary outcomes (1)
- measure
- Methylation state
- timeFrame
- 18 months
- description
- Measurement of methylation status using the Bladder CARE test (Pangea Laboratory LLC). The test, based on quantitative PCR and evaluation of methylation status in 3 target genes, is performed on a urine sample and has reported high sensitivity (94%) and specificity (93%) values in determining the presence of bladder cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patient group * age ≥ 18 years * proven diagnosis of bladder cancer (infiltrating muscle or non-infiltrating muscle) * performance status (PS) 0-1 * ability to follow the procedures established by the study * written consent for participation in the study and data processing group of healthy subjects * age ≥ 18 years * ability to follow the procedures established by the study * written consent for participation in the study and data processing Exclusion Criteria: Patient group * presence of metastatic bladder cancer * lack of autonomy in following the procedures established by the study group of healthy subjects * previous or current clinical history associated with bladder cancer * diagnostic suspicion associated with tumor pathologies * ongoing or previous systemic oncological treatments * presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile * existing pharmacological treatments (and/or any other type of treatment) that could alter the results of the analyzes conducted for the present study * lack of autonomy in following the procedures established by the study
References
Publications (0)
Data not yet available