Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples
Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma
1 other identifier
observational
131
2 countries
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedStudy Start
First participant enrolled
June 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2017
CompletedJune 8, 2017
June 1, 2017
10 months
May 2, 2016
June 7, 2017
Conditions
Keywords
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
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
- ≥ 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Seattle, Washington, 98109, United States
Unknown Facility
Rozzano, MI, 20089, Italy
Unknown Facility
Benevento, 82100, Italy
Unknown Facility
Milan, 20133, Italy
Unknown Facility
Pisa, 56126, Italy
Biospecimen
A minimum of 1 cubic mm of tumor tissue (archival) with at least 50% nucleated tumor cell content is required.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
Primary Completion
April 6, 2017
Study Completion
April 6, 2017
Last Updated
June 8, 2017
Record last verified: 2017-06