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Liquid Biopsy in Hepatocellular Carcinoma (HCCGenePanel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111029
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Madhumita Premkumar, Postgraduate Institute of Medical Education and Research

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatic Carcinoma Malignant Primary Non-Resectable Diagnostic Test: Cell Free DNA

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.

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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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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 Name: Liquid biopsy




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

Secondary Outcome Measures :
  1. Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging. [ Time Frame: 90 days ]
  2. Mortality [ Time Frame: 90 days ]

Biospecimen Retention:   Samples With DNA
Cell free DNA in Plasma will be stored


Information from the National Library of Medicine

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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
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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Madhumita Premkumar, MD DM 01722756344 drmadhumitap@gmail.com

Locations
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India
Postgraduate Institute of Medical Education and Research
Chandigarh, Choose Any State/Province, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Study Chair: Radhika Srinivasan, MD PhD Postgraduate Institute of Medical Education and Research
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Responsible Party: Madhumita Premkumar, Assistant Professor, Department of Hepatology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT04111029    
Other Study ID Numbers: INT/HEP/1078
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madhumita Premkumar, Postgraduate Institute of Medical Education and Research:
Hepatocellular carcinoma
Cell Free tumor DNA
Liquid Biopsy
Additional relevant MeSH terms:
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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