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Completed

NCT Number: NCT03162198

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cirrhosis with HCC

Other

Cirrhosis with Hepatocellular Carcinoma

Cirrhosis without HCC

Other

Cirrhosis without Hepatocellular Carcinoma

Primary outcomes

  1. Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)

    Time frame: Day 0

  2. Number of cell-free DNA (cfDNA) in cirrhotic patients with hepatocellular carcinoma (HCC)

    Time frame: Day 0

Secondary outcomes

  1. Number of Circulating Tumor Cells in the peripheral blood of cirrhotic patients in both groups

    Time frame: Day 0

  2. To study the difference in amount of cfDNA in the peripheral blood of cirrhotic patients with and without HCC.

    Time frame: Day 0

    Difference would be found out by estimating cfDNA in terms of ng/mL of the blood specimen

  3. Number of Circulatory Tumor Cells with the tumor size of HepatoCellular Carcinoma.

    Time frame: Day 0

  4. Number of Circulatory Tumor Cells with the tumor number of HepatoCellular Carcinoma.

    Time frame: Day 0

  5. Number of Circulatory Tumor Cells withBarcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.

    Time frame: Day 0

  6. Number of cfDNA amount with the tumor size of HepatoCellular Carcinoma.

    Time frame: Day 0

  7. Number of cfDNA amount with the tumor number of HepatoCellular Carcinoma.

    Time frame: Day 0

  8. Number of cfDNA amount with the Barcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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