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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162198
• Other study ID #: ILBS-HCC-03
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Neoplastic Cells, Circulating

Intervention

Other:
• Cirrhosis with HCC
Cirrhosis with Hepatocellular Carcinoma
• Cirrhosis without HCC
Cirrhosis without Hepatocellular Carcinoma

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)		Day 0
Primary	Number of cell-free DNA (cfDNA) in cirrhotic patients with hepatocellular carcinoma (HCC)		Day 0
Secondary	Number of Circulating Tumor Cells in the peripheral blood of cirrhotic patients in both groups		Day 0
Secondary	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
Secondary	Number of Circulatory Tumor Cells with the tumor size of HepatoCellular Carcinoma.		Day 0
Secondary	Number of Circulatory Tumor Cells with the tumor number of HepatoCellular Carcinoma.		Day 0
Secondary	Number of Circulatory Tumor Cells withBarcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.		Day 0
Secondary	Number of cfDNA amount with the tumor size of HepatoCellular Carcinoma.		Day 0
Secondary	Number of cfDNA amount with the tumor number of HepatoCellular Carcinoma.		Day 0
Secondary	Number of cfDNA amount with the Barcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.		Day 0