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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03483922
Date of registration: 20/03/2018
Prospective Registration: Yes
Primary sponsor: HKGepitherapeutics
Public title: HCC Screening Using DNA Methylation Changes in ctDNA
Scientific title: Clinical Trials on Detection of Hepatocellular Carcinoma With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
Date of first enrolment: August 20, 2018
Target sample size: 400
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03483922
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Bangladesh
Contacts
Name:     Wasif Ali Khan, PhD
Address: 
Telephone: 880-2-9827057
Email: wakhan@icddrb.org
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of HCC by EASL-EORTC guidelines

- Confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines.

Exclusion Criteria for HCC:

- Cirrhosis, any other known inflammatory disease (bacterial or viral infection with the
exception of hepatitis B or C, diabetes, asthma, autoimmune disease, active thyroid
disease) which could alter T cells and monocytes characteristics

- Other cancers.

Exclusion Criteria for HepB:

- Diagnosis of HCC or any other cancer.

Exclusion Criteria for Healthy Controls:

- Any known inflammatory or infectious disease including HepB and HepC

- Chronic diseases,

- Cancer

- Medications or drug use



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hepatocellular Carcinoma
Intervention(s)
Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC
Primary Outcome(s)
DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of HCC [Time Frame: 6 months to 1 year]
Secondary Outcome(s)
Secondary ID(s)
HKG-Bng-HCC-100
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
International Centre for Diarrhoeal Disease Research, Bangladesh
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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