Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma
Conditions
Keywords
FGFR2 fusion, iCCA, mixed HCC-CCA, Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma, ArQule
Brief summary
The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples
Detailed description
This is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. Approximately 150 archived tissue samples obtained from patients with iCCA or mixed HCC-CCA will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific FGFR2 fusion isoforms.
Interventions
None listed
Sponsors
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study * ≥ 18 years of age * Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing) * Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)
Exclusion criteria
* Not applicable: Patients must meet all of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples | Archived tumor samples will be collected through study completion, up to 18 months | Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA | Archived tumor samples will be collected through study completion, up to 18 months | Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel. |
| Formulate genetic screening recommendations for newly diagnosed patients with iCCA or mixed HCC-CCA | Archived tumor samples will be collected through study completion, up to 18 months | Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel. |
Countries
Italy, United States
Outcome results
None listed