Hepatic Carcinoma Malignant Primary Non-ResectableHCCGenePanelNCT04111029
Liquid Biopsy in Hepatocellular Carcinoma
An observational study of Hepatic Carcinoma Malignant Primary Non-Resectable, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Carcinoma Malignant Primary Non-Resectable
- What is being tested?
- Cell Free DNA
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 16 Jan 2020to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable
- Age 18-70 years of either sex
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Harman Dhaliwal, MSc contact
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, Choose Any State/Province, 160012
Madhumita Premkumar
About this study
Official title: 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.
Read the 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.
- Being tested
- Cell Free DNA
- Keywords
- Hepatocellular carcinoma, Cell Free tumor DNA, Liquid Biopsy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Free DNADiagnostic test
Also called Liquid biopsy
Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Cell Free DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples
Measured: 0, 90 days
Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment
Measured: 90 days
Secondary outcomes (2)
Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging.
Measured: 90 days
Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start16 Jan 2020
- Primary completion16 Dec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Carcinoma Malignant Primary Non-ResectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Radhika Srinivasan, MD PhD, Study chair, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111029
- Sponsor's protocol ID
- INT/HEP/1078
- Acronym
- HCCGenePanel
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Response to Locoregional Therapy Using Liquid Biopsy in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04111029
- Acronym / sponsor ID
- HCCGenePanel / INT/HEP/1078
- Keywords
- Hepatocellular carcinoma, Cell Free tumor DNA, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable HCC undergoing locoregional therapy | – | Diagnostic Test: Cell Free DNAPatients with unresectable HCC who have no curative option like tumour ablation, resection or transplantation and are being taken for locoregional therapy will be recruited |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable
- Age 18-70 years of either sex
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell Free DNAAlso: Liquid biopsyPre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy | Diagnostic test | Unresectable HCC undergoing locoregional therapy |
Primary outcome
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
2 secondary outcomes
Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging.
Time frame: 90 days
Mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harman Dhaliwal, MSc contact
Radhika Srinivasan, MD PhD study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Carcinoma Malignant Primary Non-Resectable, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Premkumar, MD DM (01722754777, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples (time frame: 0, 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.