Liquid Biopsy in Hepatocellular Carcinoma (HCCGenePanel)
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|ClinicalTrials.gov Identifier: NCT04111029|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment|
|Hepatic Carcinoma Malignant Primary Non-Resectable||Diagnostic Test: Cell Free DNA|
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|
|Official Title:||Assessment of Response to Locoregional Therapy Using Liquid Biopsy in Patients With Hepatocellular Carcinoma|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2021|
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
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
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 DMfirstname.lastname@example.org|
|Postgraduate Institute of Medical Education and Research|
|Chandigarh, Choose Any State/Province, India, 160012|
|Study Chair:||Radhika Srinivasan, MD PhD||Postgraduate Institute of Medical Education and Research|