CholangiocarcinomaNCT02436564
In Vitro Models of Liver and Pancreatic Cancer
An observational study of Cholangiocarcinoma and Hepatocellular Carcinoma, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangiocarcinoma, Hepatocellular Carcinoma, Pancreatic Neoplasm
- What is being tested?
- Organoid in vitro culture
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing surgical resenctions of liver, biliary or pancreas cancers that are able to give informed consent
Who may be able to join
- All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent.
Who cannot join
- Patients aged <18 or those who are unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Andrew Bradley, PhD, FRCS, (3)36976 (7)62001, jab52@cam.ac.uk
About this study
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
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.
- Being tested
- Organoid in vitro culture
- Keywords
- pancreas, stem cells, tumours, in vitro models, organoids, cancer,, bile duct, liver
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular, Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid in vitro cultureGenetic
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months.
Measured: 3 years
Secondary outcomes (1)
Proportion of tumour-derived organoids that are genetically identical to the source tumour.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Gurdon Institute, Ann McLaren Laboratory of Regenerative Medicine
- Responsible party
- Principal investigator, Dr. Kourosh Saeb-Parsy, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Kourosh Saeb-Parsy, PhD, FRCS, Principal investigator, Cambridge Univeristy Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436564
- Sponsor's protocol ID
- A093484
- Status last verified
- Jul 2016
- First submitted
- 30 Apr 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02436564
- Acronym / sponsor ID
- A093484
- Keywords
- pancreas, stem cells, tumours, in vitro models, organoids, cancer,, bile duct, liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- The Gurdon Institute, Ann McLaren Laboratory of Regenerative Medicine
- Study start
- Jul 2015
- Primary completion
- Sep 2018 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing surgical resenctions of liver, biliary or pancreas cancers that are able to give informed consent
Key inclusion criteria (1 listed)
- All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent.
Key exclusion criteria (1 listed)
- Patients aged <18 or those who are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoid in vitro cultureGeneration 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. | Genetic | – |
Primary outcome
Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months.
Time frame: 3 years
1 secondary outcome
Proportion of tumour-derived organoids that are genetically identical to the source tumour.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kourosh Saeb-Parsy, PhD, FRCS principal investigator
Cambridge Univeristy Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Hepatocellular Carcinoma, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kourosh Saeb-Parsy, PhD, FRCS ((+44 1223 7) 68456, ks10014@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.