Hepatocellular CarcinomaDELPHINCT04946773
Deep Liver Phenotyping and Immunology Study
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Hepatocellular carcinoma (HCC) and cholangiocarcinoma are the two most common causes of primary liver cancer and HCC is the second highest cause of cancer death worldwide. It is known that most of these cancers occur in patients who already have a liver condition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2021to 31 Oct 2040
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatology patients treated at a single hospital trust.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years to 75 years.
- Malignancy Cohort: extra inclusion criteria - Diagnosed with a malignancy or with clinical suspicion of a malignancy affecting the Liver or Biliary Tree.
- Control cohort: extra inclusion criteria
- Patients with confirmed chronic non-malignant hepatobiliary disease.
- Additional Inclusion Criteria for Patients Undergoing optional Liver FNA
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- Willing to undergo ultrasound guided liver FNA (unless specific contra-indications to the procedure apply).
- Has undergone appropriate clinical imaging of the upper abdomen (US/CT/MRI) within the last 12 months.
- Full blood count (FBC) and coagulation profile (Coag) checked within 30 days prior to FNA procedure (Baseline Visit).
Who cannot join
- Unable to consent.
- Pregnancy.
- Any concern by the investigator regarding the safe participation of the patient in the study; or investigator's consideration, for any other reason, that a patient is inappropriate for participation in the study.
- Additional Exclusion Criteria for Patients Undergoing optional Liver FNA (These criteria will exclude a patient from having FNA as part of the study)
- Significant comorbid medical condition(s) which may in the opinion of the investigator increase the risk of an FNA Liver.
- Coagulopathy - International Normalized Ratio (INR) >1.3, Prothrombin Time (PT) >16 seconds, Platelet count <100 x 10^3/L.
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- Known bleeding disorder (e.g. Haemophilia).
- Current use of an oral/injectable anticoagulant medication.
- Current use of an oral antiplatelet agent.
- The presence of ascites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Rory J Peters, +441865220077, Rory.peters@ndm.ox.ac.uk
About this study
Hepatocellular carcinoma (HCC) and cholangiocarcinoma are the two most common causes of primary liver cancer and HCC is the second highest cause of cancer death worldwide. It is known that most of these cancers occur in patients who already have a liver condition. Despite close monitoring of many patients who have liver disease with regular ultrasound scans, HCC and cholangiocarcinoma are often discovered at a late stage. This is because they rarely cause symptoms until they have reached an advanced stage. Early identification of these cancers would enable more patients to have curative treatments such as surgery or liver transplantation.
The investigators want to collect blood and urine samples as well as small samples of cells directly from the liver. In some cases this will be done using a technique called liver fine needle aspiration. This technique is low risk and has been successfully used in other studies. The investigators will compare samples from patients with cancer to those of patients with other diseases of the liver who are at risk of developing cancer in the future.
The investigators aim to detect changes in the liver, blood, urine and/or bile of patients who have liver conditions that could tell us their risk of a future cancer. These changes could be in the types of white blood cells found within the liver, or, they may be in products secreted by liver cells. In the latter case the liver cells may release small pieces of their DNA that could be detected in the blood. When liver cells are dysfunctional, they may also change the types of metabolic products that they produce, and the investigators may be able to detect these changes in the urine or bile.
Read the detailed description
The purpose of this study is to perform a characterisation of the cancer predisposing 'field effect' that is associated with hepatic \& hepato-biliary malignancy, and, to identify minimally invasive biomarkers that may detect this field effect. This will be achieved through collection of patient samples (Tissue/Blood/Urine/Bile). Comparisons will then be made between patients with hepatic \& hepatobiliary cancer and patients with chronic liver disease and also longitudinally in individual patients who either develop or are cured of hepatic \& hepato-biliary malignancy during the study. The investigators hope to exploit this knowledge to develop novel biomarker candidates that may ultimately form inputs to a multi-parametric early cancer detection model. The study aims are:
- Develop a cohort of patients with HCC, cholangiocarcinoma or liver metastases and a cohort of chronic liver disease patients representing all the commonly encountered aetiologies (viral, metabolic, autoimmune and alcohol related liver disease).
- Collect samples from directly within the non-cancerous liver (FNA liver/biopsy/ablation/resection specimens), blood and urine in addition tumour tissue (resection/biopsy/ablation), bile and bile duct brushings.
- Flow cytometric \& molecular biologic analysis of tissue and peripheral blood and bile.
- Transcriptomic analysis of cell populations in liver and blood.
- Genetic \& molecular biologic analysis of hepatic and immune cells and secreted products.
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma
- Keywords
- Early Detection
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malignancy Cohort | Patients with hepatic or hepatobiliary malignancy at enrolment | |
| Control Cohort | Patients with chronic liver disease but no hepatic or hepatobiliary malignancy at enrolment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of intra-hepatic and peripheral blood immune cell numbers in Malignancy Cohort and Control Cohort patients.
Proportion of immune cell populations relative to total immune cell count measured by single cell RNA sequencing.
Measured: At study enrolment
Secondary outcomes (1)
Measurement of liver cancer occurrence and all-cause mortality.
Measurement of absolute numbers of liver cancers and deaths in study patients
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start12 Mar 2021
- Primary completion31 Oct 2040 (estimated)
- Study completion31 Oct 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rory J Peters, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946773
- Sponsor's protocol ID
- 264839
- Other IDs
- C2195/A27431, CA30358/A29725
- Acronym
- DELPHI
- Status last verified
- Mar 2022
- First submitted
- 9 Jun 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Liver Phenotyping and Immunology Study
- ClinicalTrials.gov ID
- NCT04946773
- Acronym / sponsor ID
- DELPHI / 264839
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma
- Keywords
- Early Detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Oct 2040 (estimated)
- Study completion
- 31 Oct 2040 (estimated)
- First posted
- 1 Jul 2021 (actual)
- 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.
Hepatocellular carcinoma (HCC) and cholangiocarcinoma are the two most common causes of primary liver cancer and HCC is the second highest cause of cancer death worldwide. It is known that most of these cancers occur in patients who already have a liver condition. Despite close monitoring of many patients who have liver disease with regular ultrasound scans, HCC and cholangiocarcinoma are often discovered at a late stage. This is because they rarely cause symptoms until they have reached an advanced stage. Early identification of these cancers would enable more patients to have curative treatments such as surgery or liver transplantation.
The investigators want to collect blood and urine samples as well as small samples of cells directly from the liver. In some cases this will be done using a technique called liver fine needle aspiration. This technique is low risk and has been successfully used in other studies. The investigators will compare samples from patients with cancer to those of patients with other diseases of the liver who are at risk of developing cancer in the future.
The investigators aim to detect changes in the liver, blood, urine and/or bile of patients who have liver conditions that could tell us their risk of a future cancer. These changes could be in the types of white blood cells found within the liver, or, they may be in products secreted by liver cells. In the latter case the liver cells may release small pieces of their DNA that could be detected in the blood. When liver cells are dysfunctional, they may also change the types of metabolic products that they produce, and the investigators may be able to detect these changes in the urine or bile.
Detailed description
The purpose of this study is to perform a characterisation of the cancer predisposing 'field effect' that is associated with hepatic \& hepato-biliary malignancy, and, to identify minimally invasive biomarkers that may detect this field effect. This will be achieved through collection of patient samples (Tissue/Blood/Urine/Bile). Comparisons will then be made between patients with hepatic \& hepatobiliary cancer and patients with chronic liver disease and also longitudinally in individual patients who either develop or are cured of hepatic \& hepato-biliary malignancy during the study. The investigators hope to exploit this knowledge to develop novel biomarker candidates that may ultimately form inputs to a multi-parametric early cancer detection model. The study aims are:
- Develop a cohort of patients with HCC, cholangiocarcinoma or liver metastases and a cohort of chronic liver disease patients representing all the commonly encountered aetiologies (viral, metabolic, autoimmune and alcohol related liver disease).
- Collect samples from directly within the non-cancerous liver (FNA liver/biopsy/ablation/resection specimens), blood and urine in addition tumour tissue (resection/biopsy/ablation), bile and bile duct brushings.
- Flow cytometric \& molecular biologic analysis of tissue and peripheral blood and bile.
- Transcriptomic analysis of cell populations in liver and blood.
- Genetic \& molecular biologic analysis of hepatic and immune cells and secreted products.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignancy Cohort | – | –Patients with hepatic or hepatobiliary malignancy at enrolment |
| Control Cohort | – | –Patients with chronic liver disease but no hepatic or hepatobiliary malignancy at enrolment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatology patients treated at a single hospital trust.
Key inclusion criteria (9 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years to 75 years.
- Malignancy Cohort: extra inclusion criteria - Diagnosed with a malignancy or with clinical suspicion of a malignancy affecting the Liver or Biliary Tree.
- Control cohort: extra inclusion criteria
- Patients with confirmed chronic non-malignant hepatobiliary disease.
Key exclusion criteria (10 listed)
- Unable to consent.
- Pregnancy.
- Any concern by the investigator regarding the safe participation of the patient in the study; or investigator's consideration, for any other reason, that a patient is inappropriate for participation in the study.
- Additional Exclusion Criteria for Patients Undergoing optional Liver FNA (These criteria will exclude a patient from having FNA as part of the study)
- Significant comorbid medical condition(s) which may in the opinion of the investigator increase the risk of an FNA Liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of intra-hepatic and peripheral blood immune cell numbers in Malignancy Cohort and Control Cohort patients.
Time frame: At study enrolment
Proportion of immune cell populations relative to total immune cell count measured by single cell RNA sequencing.
1 secondary outcome
Measurement of liver cancer occurrence and all-cause mortality.
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Rory J Peters principal investigator
University of Oxford
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 Hepatocellular Carcinoma and Cholangiocarcinoma, run by University of Oxford 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 Apr 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rory J Peters (+441865220077, Rory.peters@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of intra-hepatic and peripheral blood immune cell numbers in Malignancy Cohort and Control Cohort patients. (time frame: At study enrolment). 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 6 Apr 2022.