Clinical trial · Observational
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
NCT02762721CI-TRIAL-00028038completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Mixed Hepatocellular Cholangiocarcinoma | Combined Hepatocellular Carcinoma and Cholangiocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
Secondary outcomes (2)
- 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
- description
- Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.