Deep Liver Phenotyping and Immunology Study

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Brief Title

Deep Liver Phenotyping and Immunology Study

Official Title

Deep Liver Phenotyping and Immunology Study

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.
    

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:

        1. 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).

        2. 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.

        3. Flow cytometric & molecular biologic analysis of tissue and peripheral blood and bile.

        4. Transcriptomic analysis of cell populations in liver and blood.

        5. Genetic & molecular biologic analysis of hepatic and immune cells and secreted products.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Measurement of intra-hepatic and peripheral blood immune cell numbers in Malignancy Cohort and Control Cohort patients.

Secondary Outcome

 Measurement of liver cancer occurrence and all-cause mortality.

Condition

Hepatocellular Carcinoma


Study Arms / Comparison Groups

 Malignancy Cohort
Description:  Patients with hepatic or hepatobiliary malignancy at enrolment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

March 12, 2021

Completion Date

October 31, 2040

Primary Completion Date

October 31, 2040

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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).

        Exclusion Criteria:

          -  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.

          -  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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Rory J Peters, +441865220077, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04946773

Organization ID

264839

Secondary IDs

C2195/A27431

Responsible Party

Sponsor

Study Sponsor

University of Oxford


Study Sponsor

Rory J Peters, Principal Investigator, University of Oxford


Verification Date

March 2022