Fluorescence in situ hybridization in the early diagnosis of cholangiocarcinoma in patients with primary sclerosing cholangitis

Fluorescence in situ hybridization in the early diagnosis of cholangiocarcinoma in patients with primary sclerosing cholangitis - FLIPPER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37613

Enrollment

125

Registered

2012-05-16

Start date

2012-05-25

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis Progressive inflammation of the bilde ducts more likely to develop into cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients from the AMC PSC surveillance cohort with PSC who will undergo ERCP indicated per standard practice.

Exclusion criteria

Exclusion criteria: Inability to pass a guidewire through the stricture

Design outcomes

Primary

Measure	Time frame
* Sensitivity, specificity, positive prognostic value (PPV) and negative prognostic value (NPV) of different FISH markers for the detection of (PSC-related) CCA.	—

Secondary

Measure	Time frame
* Sensitivity, specificity, PPV and NPV of conventional cytology. * Sensitivity, specificity, PPV and NPV of different FISH markers while preserving the specificity of cytology. * Sensitivity, specificity, PPV and NPV of FISH when FISH is positive and conventional cytology is neither positive nor suspicious for cancer.	—

Countries

Netherlands

Outcome results