Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
NCT ID: NCT03162198
Last Updated: 2019-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
53 participants
OBSERVATIONAL
2017-05-15
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Liquid Biopsy in Hepatocellular Carcinoma
NCT04111029
Circulating Tumor Cell Detection in Hepatocellular Carcinoma
NCT05297955
Characteristic and Survival Outcomes in Hepatocellular Carcinoma Patients: on Top of Viral Hepatitis Versus Combined Viral and Metabolic-Associated Steatotic Liver Disease
NCT06871930
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study
NCT00629421
Cost Effective Non Invasive Diagnostic Modalities and Predictive Model for Development and Progression of Fibrosis Among Patients With Hepatitis B, Hepatitis C Infection or Non Alcoholic Fatty Liver Disease
NCT02658786
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cirrhosis with HCC
Cirrhosis with HCC
Cirrhosis with Hepatocellular Carcinoma
Cirrhosis without HCC
Cirrhosis without HCC
Cirrhosis without Hepatocellular Carcinoma
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cirrhosis with HCC
Cirrhosis with Hepatocellular Carcinoma
Cirrhosis without HCC
Cirrhosis without Hepatocellular Carcinoma
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ILBS-HCC-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.