NCT02436564

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

3.2 years

First QC Date

April 30, 2015

Last Update Submit

July 13, 2016

Conditions

Keywords

pancreasstem cellstumoursin vitro modelsorganoidscancer,bile ductliver

Outcome Measures

Primary Outcomes (1)

  • Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months.

    3 years

Secondary Outcomes (1)

  • Proportion of tumour-derived organoids that are genetically identical to the source tumour.

    3 years

Interventions

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are undergoing surgical resenctions of liver, biliary or pancreas cancers that are able to give informed consent

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fresh tissue, frozen tissue

MeSH Terms

Conditions

CholangiocarcinomaCarcinoma, HepatocellularPancreatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Kourosh Saeb-Parsy, PhD, FRCS

    Cambridge Univeristy Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kourosh Saeb-Parsy, PhD, FRCS

CONTACT

Nikitas Georgakopoulos, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Lecturer and Consulatan Transplant Surgeon

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 7, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2018

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations