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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762721
• Other study ID #: ARQ NIS-001
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: June 7, 2017
• Start date: June 6, 2016
• Est. completion date: April 6, 2017

Study information

• Verified date: June 2017
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 6, 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Mixed Hepatocellular Cholangiocarcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples	Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.	Archived tumor samples will be collected through study completion, up to 18 months
Secondary	Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA	Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.	Archived tumor samples will be collected through study completion, up to 18 months
Secondary	Formulate genetic screening recommendations for newly diagnosed patients with iCCA or mixed HCC-CCA	Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.	Archived tumor samples will be collected through study completion, up to 18 months