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

Completed

• Conditions: Mixed Hepatocellular Cholangiocarcinoma; Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma

• Registration Number: NCT02762721
• Lead Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

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.

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-06-06
• Primary Completion: 2017-04-06
• Study Completion: 2017-04-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.