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

June 7, 2017 updated by: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Benevento, Italy, 82100
      • Milan, Italy, 20133
      • Pisa, Italy, 56126
    • MI
      • Rozzano, MI, Italy, 20089
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Washington
      • Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

One hundred and fifty archived tumor tissue samples from patients with iCCA or mixed HCC-CCA will be collected from five to fifteen research sites in the United States and Italy and/or from commercially available sources. No new surgical procedures will be required and no treatment will be provided as part of this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Archived tumor samples will be collected through study completion, up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Archived tumor samples will be collected through study completion, up to 18 months
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.
Archived tumor samples will be collected through study completion, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2016

Primary Completion (Actual)

April 6, 2017

Study Completion (Actual)

April 6, 2017

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARQ NIS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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