Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
presence of metastatic bladder cancer
lack of autonomy in following the procedures established by the study
previous or current clinical history associated with bladder cancer
diagnostic suspicion associated with tumor pathologies
Trial population
Patients affected by non-muscle infiltrating bladder cancer
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Patients suffering from bladder cancer
Group B: Healthy persons.
Trial outcomes
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
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Regina Elena Cancer Institute
Lead sponsor
Azienda Ospedaliera Santa Maria Degli Angeli
Collaborator
Istituto per lo Studio, la Prevenzione e la Rete Oncologica
Collaborator
Source ClinicalTrials.gov