Analysis of Urinary Methylation Patterns Via Liquid Biops... | NCT06878027

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

NCT06878027

Sponsor

Regina Elena Cancer Institute

Status

Recruiting

Last Update Posted

Mar 14, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2024Actual

Primary Completion Date

Feb 6, 2026Estimated

Completion Date

Feb 6, 2026Estimated

First Submitted Date

Feb 12, 2025

First Submission Date that Met QC Criteria

Mar 10, 2025

First Posted Date

Mar 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 14, 2025Actual

Name	Class
Azienda Ospedaliera Santa Maria Degli Angeli	OTHER
Istituto per lo Studio, la Prevenzione e la Rete Oncologica	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The study has the primary objective to investigate the diagnostic capacity of methylation levels in urine samples, furthermore it has the secondary objective of applying an NGS test on the urine sample capable of evaluating the highest methylation levels comprehensive, with better analytical performance than the currently available standard on the market, leveraging targeted sequencing of multiple genes or global analysis of the whole methylome.

To describe the diagnostic performance of the methods in a real-world clinical environment and identify the characteristic methylation profiles capable of stratifying patients with different prognoses, and finally to explore the potential economic impact of applying such tests as tools alternatives to conventional practices.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients affected by non-muscle infiltrating bladder cancer

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Giuseppe Simone, Medical Doctor	Contact	+39 0652665005		giuseppe.simone@ifo.it

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS National Cancer Institute "Regina Elena"	Recruiting	Rome		00144	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms