Cholangiocarcinoma Clinical Trial
Official title:
Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma
Verified date | June 2017 |
Source | ArQule |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ArQule |
United States, Italy,
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 |
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