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Clinical Trials in Italy / NCT06878027
Recruiting Observational

Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool

NCT06878027 · tracked via the Priya Life Science Italy tracker
Sponsor
Regina Elena Cancer Institute
Phase
Observational
Started
2024-08-06
Last updated
2025-03-14

Condition(s) studied

Bladder Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Methylation state — 18 months
    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

Trial sites (1)

FacilityCityRegionStatus
IRCCS National Cancer Institute "Regina Elena" Rome Italy Recruiting

More Regina Elena Cancer Institute trials in Italy

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Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population Recruiting
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Impact of Liquid Biopsy on the Therapeutic Pathway for Lung Cancer: Advancing the Molecular Characterization of Patients With Advanced Lung Adenocarcinoma by Integrating Liquid Biopsy Into the Early Stages of the Diagnostic and Therapeutic Pathway Recruiting
Generation of Endometrial Carcinoma Organoids Recruiting

Other trials for the same condition

Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population Recruiting
Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK. Recruiting
DRG Mutations in Prostate Cancer: a Guiding Light for Enhanced Screening and Personalised Therapy Active, not recruiting
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA Recruiting
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06878027 on ClinicalTrials.gov ↗ ← All trials in Italy