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Effect of DAAs on Behavior of HCC in HCV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200171
Recruitment Status : Unknown
Verified January 2018 by Mohamed Alboraie, Al-Azhar University.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Helwan University
Cairo University
Ain Shams University
Information provided by (Responsible Party):
Mohamed Alboraie, Al-Azhar University

Brief Summary:
Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).

Condition or disease
Carcinoma, Hepatocellular Hepatitis C

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Direct Acting Antiviral Agents on Behavior of Hepatocellular Carcinoma and Overall Survival in Patients With Chronic Hepatitis C
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Group I
HCC patients who received DAAs for chronic HCV previously (either responders or not)
Group II
HCC patients who are naive to DAAs.



Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 6 months - 3 years ]
    he length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

  2. Behavior of hepatocellular carcinoma [ Time Frame: 6 months - 3 years ]
    Early recurrence, or rapid progression


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 6 months - 3 years ]
    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Progression-free survival (PFS) will be measured by the Independent Radiological Review according to RECIST 1.1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HCV related Hepatocellular carcinoma (HCC)
Criteria

Inclusion Criteria:

  • Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups:
  • Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not)
  • Group II: HCC patients who are naive to DAAs.

Exclusion Criteria:

  • Patients who refuse to be enrolled in the study.
  • Patients with hepatitis B virus or any other causes of cirrhosis.
  • Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven.
  • HCC developed on transplanted liver.

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): NCT03200171


Contacts
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Contact: Mohamed Alboraie, M.D. 00201222717078 alboraie@azhar.edu.eg

Locations
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Egypt
MOHAMED Alboraie Recruiting
Cairo, Egypt, 11651
Contact: MOHAMED A Alboraie, M.D.    00201222717078    alboraie@azhar.edu.eg   
Principal Investigator: Mohamed A Alboraie, M.D.         
Helwan University Recruiting
Cairo, Egypt
Contact: Mohamed El Kassas, MD         
National Hepatology and Tropical Medicine Research Institute Recruiting
Cairo, Egypt
Contact: Mohamed Hassany, MD         
Sponsors and Collaborators
Al-Azhar University
Helwan University
Cairo University
Ain Shams University
Investigators
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Principal Investigator: Mohamed Alboraie, M.D. Al-Azhar University
Publications of Results:
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Responsible Party: Mohamed Alboraie, Principal Investigator, Al-Azhar University
ClinicalTrials.gov Identifier: NCT03200171    
Other Study ID Numbers: EARTH-HCC-1
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Alboraie, Al-Azhar University:
Carcinoma, Hepatocellular
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Carcinoma
Carcinoma, Hepatocellular
Hepatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site