Liquid Biopsy in Hepatocellular Carcinoma

NCT04111029 | Unknown DMC

• 1 other identifier: INT/HEP/1078
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Carcinoma Malignant Primary Non-Resectable

Keywords

Hepatocellular carcinoma; Cell Free tumor DNA; Liquid Biopsy

Outcome Measures

Primary Outcomes (2)

• Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples

  0, 90 days

• Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment

  90 days

Secondary Outcomes (2)

• Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging.

  90 days

• Mortality

  90 days

Study Arms (1)

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

Interventions

Cell Free DNA DIAGNOSTIC_TEST

Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy

Also known as: Liquid biopsy

Unresectable HCC undergoing locoregional therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable
• Age 18-70 years of either sex

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Choose Any State/Province, 160012, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cell free DNA in Plasma will be stored

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Noninvasive Prenatal Testing; Liquid Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Testing; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Radhika Srinivasan, MD PhD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Central Study Contacts

Madhumita Premkumar, MD DM

CONTACT

01722754777; drmadhumitap@gmail.com

Harman Dhaliwal, MSc

CONTACT

0117087003409

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Hepatology

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: January 16, 2020
• Primary Completion: December 16, 2023
• Study Completion: March 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

IN (1)