In Vitro Models of Liver and Pancreatic Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

A Study Designed to Develop in Vitro Models of Liver, Biliary and Pancreatic Cancer for the Investigation of Tumour Biology and Potential Therapies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436564
• Other study ID #: A093484
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2015
• Last updated: July 13, 2016
• Start date: July 2015

Study information

• Verified date: July 2016
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Kourosh Saeb-Parsy, PhD, FRCS
• Phone: (+44 1223 7) 68456
• Email: ks10014[@]cam.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The primary objective is to develop an in vitro model of cancer for laboratory study using liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the investigators hope to compare molecular and cellular biology of cancer cells with normal cells as well as potentially test the efficacy of current and future anti-cancer therapies.

Samples will be collected from tissue that has been resected as part of the treatment for a patient diagnosed with liver, bile duct or pancreas cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent.

Exclusion Criteria:

• Patients aged <18 or those who are unable to give informed consent.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Genetic:
• Organoid in vitro culture
Generation of 'organoids' using in vitro culture techniques, genomic DNA and RNA sequencing, application of genome editing technology, investigation of anti-tumour drugs, investigation of biological and functional properties of tumour cells, transplantation of organoid lines into animal models.

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Ann McLaren Laboratory of Regenerative Medicine, The Gurdon Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months.		3 years	No
Secondary	Proportion of tumour-derived organoids that are genetically identical to the source tumour.		3 years	No