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Spots Global Cancer Trial Database for Next Generation Sequencing in Intrahepatic Cholangiocarcinoma

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Trial Identification

Brief Title: Next Generation Sequencing in Intrahepatic Cholangiocarcinoma

Official Title: Next Generation Sequencing in Intrahepatic Cholangiocarcinoma (ICC) According to the Stratification of the Risk Factors

Study ID: NCT02184871

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Policlinico S.Orsola- Malpighi, S.S.D. Oncologia Medica- Biasco, Bologna, BO, Italy

Contact Details

Name: Giovanni Brandi

Affiliation: University of Bologna

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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