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

Sponsor

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)

Overall Status

Completed

CT.gov ID

NCT02762721

Collaborator

(none)

131

Enrollment

Locations

Actual Duration (Months)

21.8

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma Mixed Hepatocellular Cholangiocarcinoma Cholangiocarcinoma

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 Design

Study Type:

Observational

Actual Enrollment :

131 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma

Actual Study Start Date :

Jun 6, 2016

Actual Primary Completion Date :

Apr 6, 2017

Actual Study Completion Date :

Apr 6, 2017

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)