Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

The aim of this study is to identify a dysplasia- and CCA-specific NGS panel to increase the diagnostic sensitivity of histological and/or cytological examination of biliary tract stenosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA).

Age greater than/equal to 18 years.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • NGS

    Diagnostic test

    Tissue samples will be processed and analysed at the U.O. of Pathological Anatomy

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients undergoing biliary tract resectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Identification of an NGS panel specific to dysplasia and CCA

Ratio between the number of cases identified with NGS panel and the number of cases identified with standard of care

Time frame
During enrollment period, up to 30 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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