Liquid Biopsy in Hepatocellular Carcinoma (HCCGenePanel)

April 28, 2023 updated by: Madhumita Premkumar, Postgraduate Institute of Medical Education and Research

Assessment of Response to Locoregional Therapy Using Liquid Biopsy in Patients With Hepatocellular Carcinoma

Circulating tumor DNA (ctDNA) carrying tumor-specific sequence alterations has been found in the cell-free fraction of blood. Hepatocellular carcinoma (HCC) specimens are difficult to obtain, and noninvasive methods are required to assess cancer progression and characterize underlying genomic features. Use of 'liquid biopsy' by assessing circulating cell free DNA enables the clinician to offer targeted immunotherapy or signaling pathway inhibitors. It also offers a model to prove response to locoregional or immunotherapy therapy and predict tumor recurrence non-invasively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Harman Dhaliwal, MSc
  • Phone Number: 0117087003409

Study Locations

  • India
    • Choose Any State/Province
      • Chandigarh, Choose Any State/Province, India, 160012
        • Recruiting
        • Postgraduate Institute of Medical Education and Research
        • Contact:
          • Madhumita Premkumar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Liquid biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples
Time Frame: 0, 90 days
0, 90 days
Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 90 days
90 days
Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Study Chair: Radhika Srinivasan, MD PhD, Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2020

Primary Completion (Anticipated)

December 16, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 28, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT/HEP/1078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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