Deep Liver Phenotyping and Immunology Study

NCT04946773 | Recruiting

• 3 other identifiers: 264839C2195/A27431CA30358/A29725
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hepatocellular Carcinoma; Cholangiocarcinoma

Keywords

Early Detection

Outcome Measures

Primary Outcomes (1)

• 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.

  At study enrolment

Secondary Outcomes (1)

• Measurement of liver cancer occurrence and all-cause mortality.

  15 years

Other Outcomes (2)

• Measure safety of fine needle aspiration in cirrhosis

  5 years

• Measure tolerability of liver fine needle aspiration

  5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatology patients treated at a single hospital trust.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years to 75 years.
• \- Patients with confirmed chronic non-malignant hepatobiliary disease.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, urine \& bile

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Rory J Peters

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rory J Peters

CONTACT

+441865220077; Rory.peters@ndm.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 1, 2021
• Study Start: March 12, 2021
• Primary Completion (Estimated): October 31, 2040
• Study Completion (Estimated): October 31, 2040
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

GB (1)