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

NCT06878027 | Recruiting

• 1 other identifier: RS194/IRE/24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

methylation levels in urine samples

Outcome Measures

Primary Outcomes (1)

• Methylation state

  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

  18 months

Study Arms (2)

Patients suffering from bladder cancer

Patients with a proven diagnosis of muscle-infiltrating or non-muscle-infiltrating bladder cancer, having performance status (PS) 0-1.

Healthy persons.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by non-muscle infiltrating bladder cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Azienda Ospedaliera Santa Maria Degli Angeli: collaborator
• Istituto per lo Studio, la Prevenzione e la Rete Oncologica: collaborator

Study Sites (1)

IRCCS National Cancer Institute "Regina Elena"

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

methylation levels in urine samples.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Giuseppe Simone, Medical Doctor

CONTACT

+39 0652665005; giuseppe.simone@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 14, 2025
• Study Start: August 6, 2024
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

IT (1)