Risk of HCC in Cirrhotic Patients Post DAAs Ttt

NCT03414554 | Unknown

• 1 other identifier: HCCDAAs
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. This type of treatment has now completely replaced interferon-based therapy .Therapy of chronic hepatitis C with direct-acting antivirals (DAAs) is able to induce a sustained virological response (SVR) in over 85% of patients, even if liver cirrhosis is present. Cirrhotic patients should be closely monitored after treatment.HCC is thought to develop over time as the liver is exposed to inflammation and develops fibrosis. Thus, if DAAs can eliminate inflammation mediated by HCV, the risk of HCC should decrease. However, several centers have observed that this actually may not be the case. Tumor genesis occurs through a multistep, multifactorial process. Eliminating HCV-induced inflammation may not be enough to decrease risk of HCC.DAAs have provided an effective, well tolerated treatment for hepatitis C in patents with cirrhosis . However, several studies have shown unexpectedly high rates of recurrence of HCC in the early post DAAs treatment time period.

1. 1.Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.
2. 2.To asses diagnostic value of novel markers in patients who developed hepatocellular carcinoma (HCC) after (DAAs)

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Occurrence and risk factors for HCC post DAAs

  Perecentage of occurrence of hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.

  One year

Secondary Outcomes (1)

• Diagnostic value of miRNA in patients who developed HCC post DAAs

  One Year

Study Arms (1)

HCV patients receiving DAAs

Patients with HCV-related liver cirrhosis (eligible for treatment) who will recieve DAAs therapy with one year follow up.markers: miR121, miR122, miR124will be assessed in both groups before and after DAAs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is a prospective study that will be carried out on patients with HCV-related liver cirrhosis treated with direct acting antiviral drugs at ALRAJHI Liver hospital, Assiut university from February 2018 to December 2019.

You may qualify if:

• Patients with HCV-related liver cirrhosis (eligible for treatment) who developed (HCC) after DAAs therapy within one year follow up.
• Age and sex matched group of patients with HCV- related liver cirrhosis who didn't develop HCC after DAAs therapy within one year follow up(as control group)
• Patients with chronic HCV related liver cirrhosis complicated by hepatocellular carcinoma not eligible for treatment.(discovered during enrollment in HCV treatment program)

You may not qualify if:

• Patients who refuse to participate in the study.
• Patients with hepatitis B virus, any other causes of cirrhosis.(Alcohol consumpation, Biliary, Cardiac…..etc)
• Patients with cancers other than HCC or metastatic liver cancer.
• Patients who developed HCC on transplanted liver.
• Patients who previously treated for HCC.
• Patients who receive any immunosuppression drugs.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Wartelle-Bladou C, Le Folgoc G, Bourliere M, Lecomte L. Hepatitis C therapy in non-genotype 1 patients: the near future. J Viral Hepat. 2012 Aug;19(8):525-36. doi: 10.1111/j.1365-2893.2012.01634.x.

  PMID: 22762136 BACKGROUND

• Xu J, Wu C, Che X, Wang L, Yu D, Zhang T, Huang L, Li H, Tan W, Wang C, Lin D. Circulating microRNAs, miR-21, miR-122, and miR-223, in patients with hepatocellular carcinoma or chronic hepatitis. Mol Carcinog. 2011 Feb;50(2):136-42. doi: 10.1002/mc.20712. Epub 2010 Dec 10.

  PMID: 21229610 BACKGROUND

• Pawlotsky JM, Feld JJ, Zeuzem S, Hoofnagle JH. From non-A, non-B hepatitis to hepatitis C virus cure. J Hepatol. 2015 Apr;62(1 Suppl):S87-99. doi: 10.1016/j.jhep.2015.02.006.

  PMID: 25920094 BACKGROUND

• Omar A, Abou-Alfa GK, Khairy A, Omar H. Risk factors for developing hepatocellular carcinoma in Egypt. Chin Clin Oncol. 2013 Dec;2(4):43. doi: 10.3978/j.issn.2304-3865.2013.11.07.

  PMID: 25841922 BACKGROUND

• Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011 Feb;17(2):107-15. doi: 10.1111/j.1469-0691.2010.03432.x.

  PMID: 21091831 BACKGROUND

Study Officials

• Alshaimaa Rafat, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alshaimaa Rafat, MD

CONTACT

01004206006; shosho_rafat@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator at Tropical medicine and Gastroenterology Department

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: February 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: February 28, 2019
• Last Updated: January 30, 2018

Record last verified: 2018-01