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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Other: Cirrhosis with HCC; Other: Cirrhosis without HCC

Study type: Observational

Funder types: Other

Identifiers

NCT03162198

ILBS-HCC-03

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

53 participants in 2 patient groups

Cirrhosis with HCC

Treatment:

Other: Cirrhosis with HCC

Cirrhosis without HCC

Treatment:

Other: Cirrhosis without HCC