Effect of DAAs on Behavior of HCC in HCV Patients

NCT03200171 | Completed

• 1 other identifier: EARTH-HCC-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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).

Conditions

Carcinoma, Hepatocellular; Hepatitis C

Keywords

Carcinoma, Hepatocellular; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  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.

  6 months - 3 years

• Behavior of hepatocellular carcinoma

  Early recurrence, or rapid progression

  6 months - 3 years

Secondary Outcomes (1)

• Progression-free survival (PFS)

  6 months - 3 years

Study Arms (2)

Group I

HCC patients who received DAAs for chronic HCV previously (either responders or not)

Group II

HCC patients who are naive to DAAs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HCV related Hepatocellular carcinoma (HCC)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead
• Helwan University: collaborator
• Cairo University: collaborator
• Ain Shams University: collaborator

Study Sites (3)

MOHAMED Alboraie

Cairo, 11651, Egypt

Location

Helwan University

Cairo, Egypt

Location

National Hepatology and Tropical Medicine Research Institute

Cairo, Egypt

Location

Related Publications (1)

• Reig M, Marino Z, Perello C, Inarrairaegui M, Ribeiro A, Lens S, Diaz A, Vilana R, Darnell A, Varela M, Sangro B, Calleja JL, Forns X, Bruix J. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol. 2016 Oct;65(4):719-726. doi: 10.1016/j.jhep.2016.04.008. Epub 2016 Apr 13.

  PMID: 27084592 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• Mohamed Alboraie, M.D.

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: June 27, 2017
• Study Start: February 10, 2018
• Primary Completion: June 19, 2021
• Study Completion: July 19, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)