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

Descriptive Information
Brief Title † Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples
Official Title † Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma
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 Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
Secondary Outcome Measure † Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA
Condition † Intrahepatic Cholangiocarcinoma Mixed Hepatocellular Cholangiocarcinoma Cholangiocarcinoma
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 131
Start Date † June 6, 2016
Completion Date April 6, 2017
Primary Completion Date April 6, 2017
Eligibility Criteria † 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 All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Italy
Administrative Information
NCT ID † NCT02762721
Organization ID ARQ NIS-001
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † ArQule
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date June 2017
First Received Date † May 2, 2016
Last Updated Date June 7, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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