NCT04946773Recruiting
Deep Liver Phenotyping and Immunology Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 9 Jun 2021
- Start date
- 12 Mar 2021
- Primary completion date
- 31 Oct 2040
- Lead sponsor
- University of Oxford
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04946773
What you commit to
- Study type: Observational
- Planned participants: 100
- From 12 Mar 2021 to the primary completion date, 31 Oct 2040
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of an oral/injectable anticoagulant medication.
Other illness
- Significant comorbid medical condition(s) which may in the opinion of the investigator increase the risk of an FNA Liver.
- Known bleeding disorder (e.g. Haemophilia).
Lab values
- Coagulopathy - International Normalized Ratio (INR) \>1.3, Prothrombin Time (PT) \>16 seconds, Platelet count \<100 x 10\^3/L.
Other
- 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)
- Current use of an oral antiplatelet agent.
- The presence of ascites.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.