Clinical trial NCT02762721: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrahepatic Cholangiocarcinoma
Mixed Hepatocellular Cholangiocarcinoma
Cholangiocarcinoma
Keywords: FGFR2 fusion
iCCA
mixed HCC-CCA
Intrahepatic Cholangiocarcinoma
Mixed Hepatocellular Cholangiocarcinoma
Cholangiocarcinoma
ArQule
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
timeFrame: Archived tumor samples will be collected through study completion, up to 18 months
Secondary outcomes:
measure: Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA
timeFrame: Archived tumor samples will be collected through study completion, up to 18 months
measure: Formulate genetic screening recommendations for newly diagnosed patients with iCCA or mixed HCC-CCA
timeFrame: Archived tumor samples will be collected through study completion, up to 18 months
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Seattle
country: United States
state: Washington
city: Rozzano
country: Italy
state: MI
city: Benevento
country: Italy
city: Milan
country: Italy
city: Pisa
country: Italy
Study officials:
References: