Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples

Overview

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

Full Title of Study: “Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: April 6, 2017

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.

Clinical Trial Outcome Measures

Primary Measures

  • Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
    • Time Frame: 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 Measures

  • Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ArQule
  • Provider of Information About this Clinical Study
    • Sponsor

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