Next Generation Sequencing in Intrahepatic Cholangiocarcinoma

NCT02184871 | Unknown

• 1 other identifier: 21/2014/U/Tess
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

intrahepatic cholangiocarcinoma; RNAseq; risk factors; asbestos

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

intrahepatic cholangiocarcinoma

Patients committed to surgery and stratified according to exposure to different risk factors for ICC, basing on modified ReNaM questionnaire.

Other: exposure to different risk factors and molecular assessment

Interventions

exposure to different risk factors and molecular assessment OTHER

intrahepatic cholangiocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• patients who have been treated with any medical treatment (chemotherapy or experimental standard) or with radiotherapy during the last 5 years.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Policlinico S.Orsola- Malpighi, S.S.D. Oncologia Medica- Biasco

Bologna, BO, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Giovanni Brandi

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD, PhD

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

IT (1)