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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.
Exposure to distinct risk factors of the enrolled ICC patients will be assessed by modified ReNaM questionnaire. Molecular characterization of ICC tissue samples will be carried out by RNAseq. Briefly, after surgical resection tissue samples will be immediately suspended in RNAlater. RNAseq analysis will be performed on the Illumina HiScanSQ platform. Any possible mutations identified by RNAseq will be validated by Sanger sequencing. Putative identified fusion transcripts will be confirmed by RT-PCR, using specific primers pairs located on the sequences from the exons of the two putative fusion genes. Variations in gene expression will be validated by the real-time PCR. The bioinformatic analysis will be made by using CentOS5 Server. For evaluation of asbestos fibers in tumor tissues, samples embedded in paraffin will be incinerated and then analyzed in a scanning electron microscope and by EDS spectroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intrahepatic cholangiocarcinoma | Patients committed to surgery and stratified according to exposure to different risk factors for ICC, basing on modified ReNaM questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exposure to different risk factors and molecular assessment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of molecular biomarkers in ICC patients exposed to different risk factors. | 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). | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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ICC patients candidate for curative-intent surgery, for a total of 45 subjects. For each patient enrolled, histological examination of tumor tissue specimen will be performed in order to confirm ICC diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Brandi | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S.Orsola- Malpighi, S.S.D. Oncologia Medica- Biasco | Recruiting | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Tumor tissue samples will be immediately collected after surgery: one part will be suspended in RNAlater to prevent RNA degradation and stored at -20°C, the other will be formalin-fixed and paraffin-embedded for histopathology examination and evaluation of asbestos fibers. For each patient enrolled, peripheral blood will be also collected and stored at -20°C. Total RNA and genomic DNA will be extracted from tumor tissue and peripheral blood and stored at -80°C until use.
| D009369 | Neoplasms |