Deep Liver Phenotyping and Immunology Study (DELPHI)
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ClinicalTrials.gov Identifier: NCT04946773 |
Recruitment Status :
Recruiting
First Posted : July 1, 2021
Last Update Posted : April 6, 2022
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Tracking Information | |||||
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First Submitted Date | June 9, 2021 | ||||
First Posted Date | July 1, 2021 | ||||
Last Update Posted Date | April 6, 2022 | ||||
Actual Study Start Date | March 12, 2021 | ||||
Estimated Primary Completion Date | October 31, 2040 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures |
Defining the differences in the hepatic immune microenvironment that are associated with malignancy. [ Time Frame: At study enrolment ] Between group comparison of intra-hepatic and peripheral immune cell populations determined by single cell RNA sequencing.
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Change History | |||||
Current Secondary Outcome Measures |
Measurement of liver cancer occurrence and all-cause mortality. [ Time Frame: 15 years ] Measurement of absolute numbers of liver cancers and deaths in study patients
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
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. |
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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:
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 15 Years | ||||
Biospecimen | Retention: Samples With DNA Description: Tissue, blood, urine & bile
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Sampling Method | Non-Probability Sample | ||||
Study Population | Hepatology patients treated at a single hospital trust. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | October 31, 2040 | ||||
Estimated Primary Completion Date | October 31, 2040 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
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
Exclusion Criteria:
Additional Exclusion Criteria for Patients Undergoing optional Liver FNA (These criteria will exclude a patient from having FNA as part of the study)
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04946773 | ||||
Other Study ID Numbers | 264839 C2195/A27431 ( Other Grant/Funding Number: Cancer Research UK ) CA30358/A29725 ( Other Grant/Funding Number: Cancer Research UK ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | University of Oxford | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | University of Oxford | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University of Oxford | ||||
Verification Date | March 2022 |