Trials Sponsors Conditions Drugs Pricing

Conditions

Cholangiocarcinoma Intrahepatic Cholangiocarcinoma Mixed Hepatocellular Cholangiocarcinoma

Keywords

FGFR2 fusioniCCAmixed HCC-CCAIntrahepatic CholangiocarcinomaMixed Hepatocellular CholangiocarcinomaCholangiocarcinomaArQule

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

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
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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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

Sponsors & Collaborators

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industrylead

Study Sites (6)

Atlanta, Georgia, 30322, United States

Seattle, Washington, 98109, United States

Rozzano, MI, 20089, Italy

Benevento, 82100, Italy

Milan, 20133, Italy

Pisa, 56126, Italy

Biospecimen

Retention: SAMPLES WITH DNA

A minimum of 1 cubic mm of tumor tissue (archival) with at least 50% nucleated tumor cell content is required.

MeSH Terms

Conditions

CholangiocarcinomaLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Enrollment

131 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: CROSS SECTIONAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 5, 2016

Study Start

June 6, 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations