In Vitro Models of Liver and Pancreatic Cancer | NCT02436564

Studies
In Vitro Models of Liver and Pancreatic Cancer

NCT02436564

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Status

Unknown status

Last Update Posted

Jul 14, 2016Estimated

Enrollment

75Estimated

Phase

Not provided

Conditions

Cholangiocarcinoma
Hepatocellular Carcinoma
Pancreatic Neoplasm

Interventions

Organoid in vitro culture

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Sep 2018Estimated

Completion Date

Not provided

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

May 4, 2015

First Posted Date

May 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Kourosh Saeb-Parsy, University Lecturer and Consulatan Transplant Surgeon, Cambridge University Hospitals NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Cambridge University Hospitals NHS Foundation TrustOTHER

Collaborators

Name	Class
The Gurdon Institute	UNKNOWN
Ann McLaren Laboratory of Regenerative Medicine	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Organoid in vitro culture	Genetic	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months.		3 years

Secondary Outcomes

Measure	Description	Time Frame
Proportion of tumour-derived organoids that are genetically identical to the source tumour.		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kourosh Saeb-Parsy, PhD, FRCS	Contact	(+44 1223 7) 68456		ks10014@cam.ac.uk
Nikitas Georgakopoulos, BSc	Contact	07554003700		ng395@cam.ac.uk

Overall Officials

Name	Affiliation	Role
Kourosh Saeb-Parsy, PhD, FRCS	Cambridge Univeristy Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addenbrooke's Hospital	Recruiting	Cambridge		CB2 0QQ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma
D006528	Carcinoma, Hepatocellular
D010190	Pancreatic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided