Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)

All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for inclusion.Based on the previous years data of HCC patients admitted to ILBS.

Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the Study of Liver Disease (AASLD) guidelines (details in appendix1).

Age and gender matched patients with cirrhosis, but without HCC, seen during the same study period will serve as controls.

Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted. Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Other: Cirrhosis with HCC; Other: Cirrhosis without HCC

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Proven cirrhosis with HCC proven by standard radiological criteria within last 1 month.
• Proven cirrhosis with no HCC on dynamic CT and/or dynamic MRI done within last 1 month.

Description

Inclusion Criteria:

• Age between 18-70 years.
• Proven cirrhosis (Defined in appendix 1).
• HCC proven by standard radiological criteria within last 1-month (For Cases)
• No HCC on dynamic CT and/or dynamic MRI (protocol defined in appendix 1) done within last 1 month (For Control Group).

Exclusion Criteria:

• Previous biopsy or FNA of the tumor.
• Previous invasive radiological procedures TACE/RFA.
• Previous or ongoing chemotherapy or biological therapy.
• Previous liver resection or transplant.
• Segmental / main PV thrombosis.
• Atypical enhancement on imaging
• Extrahepatic metastatic spread of HCC
• >70 years of age
• Coexisting sepsis.
• Renal dysfunction, as defined by serum creatinine >1.5mg/dL.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cirrhosis with HCC	Other: Cirrhosis with HCC; Cirrhosis with Hepatocellular Carcinoma
Cirrhosis without HCC	Other: Cirrhosis without HCC; Cirrhosis without Hepatocellular Carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)	Day 0
Number of cell-free DNA (cfDNA) in cirrhotic patients with hepatocellular carcinoma (HCC)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Circulating Tumor Cells in the peripheral blood of cirrhotic patients in both groups		Day 0
To study the difference in amount of cfDNA in the peripheral blood of cirrhotic patients with and without HCC.	Difference would be found out by estimating cfDNA in terms of ng/mL of the blood specimen	Day 0
Number of Circulatory Tumor Cells with the tumor size of HepatoCellular Carcinoma.		Day 0
Number of Circulatory Tumor Cells with the tumor number of HepatoCellular Carcinoma.		Day 0
Number of Circulatory Tumor Cells withBarcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.		Day 0
Number of cfDNA amount with the tumor size of HepatoCellular Carcinoma.		Day 0
Number of cfDNA amount with the tumor number of HepatoCellular Carcinoma.		Day 0
Number of cfDNA amount with the Barcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.		Day 0

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ACTUAL): October 31, 2018
• Study Completion (ACTUAL): October 31, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Carcinoma; Carcinoma, Hepatocellular; Neoplastic Cells, Circulating
• Other Study ID Numbers: ILBS-HCC-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No