Liquid Biopsy in Hepatocellular Carcinoma (HCCGenePanel)
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ClinicalTrials.gov Identifier: NCT04111029 |
Recruitment Status :
Recruiting
First Posted : October 1, 2019
Last Update Posted : May 3, 2023
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Condition or disease | Intervention/treatment |
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Hepatic Carcinoma Malignant Primary Non-Resectable | Diagnostic Test: Cell Free DNA |
Novelty:
Mutation analysis may not only help identify cancer drivers, but they can also provide useful data to predict response to other treatment modalities such as immunotherapies, particularly immune checkpoint blockade. There is published data on liquid biopsy in India from oncology in the field of pulmonary and renal cancers, but these studies have not been done in cirrhosis or in HCC patients.
Objectives In this project we hope to develop a biomarker panel which helps us prognosticate patients and tailor targeted therapy as per their genetic mutation landscape. The treatment options for advanced HCC are limited, and tissue biopsy is not routinely performed.
Methods In this pilot project, we will analyze 30 patients with unresectable hepatocellular carcinoma, ineligible for liver transplantation, who will undergo locoregional therapy in the form of transarterial chemoembolization (TACE) or radioembolization (TARE) for tissue diagnosis of tumor tissue DNA and circulating tumor DNA. We will design personalized assays targeting somatic rearrangements of each tumor to quantify serum ctDNA. Exome sequencing will be performed using cell-free DNA and paired primary tumor tissue DNA in order to create a non-invasive liquid biopsy for diagnosis and prognostication of HCC.
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Assessment of Response to Locoregional Therapy Using Liquid Biopsy in Patients With Hepatocellular Carcinoma |
Actual Study Start Date : | January 16, 2020 |
Estimated Primary Completion Date : | December 16, 2023 |
Estimated Study Completion Date : | March 2024 |
Group/Cohort | Intervention/treatment |
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Unresectable HCC undergoing locoregional therapy
Patients with unresectable HCC who have no curative option like tumour ablation, resection or transplantation and are being taken for locoregional therapy will be recruited
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Diagnostic Test: Cell Free DNA
Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy
Other Name: Liquid biopsy |
- Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples [ Time Frame: 0, 90 days ]
- Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment [ Time Frame: 90 days ]
- Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging. [ Time Frame: 90 days ]
- Mortality [ Time Frame: 90 days ]
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
A) All new consecutively diagnosed cases of Hepatocellular carcinoma (HCC) fulfilling the inclusion criteria, presenting to the Hepatology OPD and admitted to the LICU and/or wards for loco-regional therapy for the first time.
- All new cases of HCC diagnosed as per the AASLD 2018 guideline. HCC will be staged according to the Barcelona Clinic Liver Cancer (BCLC- Staging) system.
- The patients undergoing their first LRT (TACE/TARE/SBRT) with or without Sorafenib for HCC who are not eligible for resection/ liver transplantation or any other curative modality.
- Treatment allocation, as per the updated BCLC staging system and treatment strategy, which is also endorsed by the AASLD guidelines for the management of HCC
Inclusion Criteria:
- Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable
- Age 18-70 years of either sex
Exclusion Criteria:
- Contemplating Hepatic resection or OLT
- Refractory ascites
- Severe Coagulation disorders prior to the procedure (PTI <70% and Platelet count < 80,000/mm3)
- Hepato-Renal syndrome
- Chronic Kidney Disease
- Acute decompensation like Hepatic encephalopathy and variceal bleeding
- Any known malignancy other than HCC
- Life expectancy < 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111029
Contact: Madhumita Premkumar, MD DM | 01722754777 | drmadhumitap@gmail.com | |
Contact: Harman Dhaliwal, MSc | 0117087003409 |
India | |
Postgraduate Institute of Medical Education and Research | Recruiting |
Chandigarh, Choose Any State/Province, India, 160012 | |
Contact: Madhumita Premkumar |
Study Chair: | Radhika Srinivasan, MD PhD | Post Graduate Institute of Medical Education and Research, Chandigarh |
Responsible Party: | Madhumita Premkumar, Assistant Professor, Department of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh |
ClinicalTrials.gov Identifier: | NCT04111029 |
Other Study ID Numbers: |
INT/HEP/1078 |
First Posted: | October 1, 2019 Key Record Dates |
Last Update Posted: | May 3, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatocellular carcinoma Cell Free tumor DNA Liquid Biopsy |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |