Clinical trial · Observational
Next Generation Sequencing in Intrahepatic Cholangiocarcinoma
Next Generation Sequencing in Intrahepatic Cholangiocarcinoma (ICC) According to the Stratification of the Risk Factors
NCT02184871CI-TRIAL-00015043EtherBilunknownClinicalTrials.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 aim of the present study is to perform a comprehensive molecular characterization of intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk factors (such as asbestos) for this malignancy, in order to identify possible "molecular signatures" associated to such different risk factors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exposure to different risk factors and molecular assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- intrahepatic cholangiocarcinoma
- description
- Patients committed to surgery and stratified according to exposure to different risk factors for ICC, basing on modified ReNaM questionnaire.
- interventionNames
- Other: exposure to different risk factors and molecular assessment
Primary outcomes (1)
- measure
- Identification of molecular biomarkers in ICC patients exposed to different risk factors.
- timeFrame
- 3 years
- description
- For each patient enrolled, molecular profile of ICC tissue samples will be correlated to the anamnestic data collected by modified ReNaM questionnaire. For bio-informatic analysis, the collected data will be analyzed in order to identify signals that significantly deviate from the expected SNVs distribution in the general population, then analyzing the presence of clustering for the selected genes group. A two-way unsupervised hierarchical clustering analysis will be run to assess gene expression in the study groups (exposed / unexposed to the different risk factors). Random permutation test will be also conducted to assess the presence of genes whose expression is different in the study groups. Statistical analyses will be conducted using the R software (R Foundation and for Statistical Computing).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients having a confirmed diagnosis of ICC resected; * patients who have signed the informed consent; * patients (males or females) who are at least 18 years old. Exclusion Criteria: * patients who have been treated with any medical treatment (chemotherapy or experimental standard) or with radiotherapy during the last 5 years.
References
Publications (0)
Data not yet available
No reference posted for this study.