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

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ClinicalTrials.gov Identifier: NCT03162198
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief 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.


Condition or disease Intervention/treatment
Hepatocellular Carcinoma Other: Cirrhosis with HCC Other: Cirrhosis without HCC

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 25, 2019
Estimated Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous biopsy or FNA of the tumor.1
  • Previous invasive radiological procedures TACE/RFA.
  • Previous or ongoing chemotherapy or biological therapy.
  • Previous liver resection or transplant.
  • Segmental / main PV thrombosis.2
  • Atypical enhancement on imaging
  • Extrahepatic metastatic spread of HCC3
  • >70 years of age4
  • Coexisting sepsis.
  • Renal dysfunction, as defined by serum creatinine >1.5mg/dL.5

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162198


Contacts
Contact: Dr Manjul Mishra, MD 01146300000 manjul2883@gmail.com

Locations
India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03162198     History of Changes
Other Study ID Numbers: ILBS-HCC-03
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplastic Cells, Circulating
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes