Association Between Serum Ferritin Level and Severity of Liver Disease and Development of HCC in Cirrhotic Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401890
Collaborator
(none)
102
14

Study Details

Study Description

Brief Summary

Association between serum ferritin level and severity of liver disease and development of HCC in cirrhotic patients .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    th leading cause of cancer mortality worldwide, with an estimated 841,000 (9.3 cases per 100,000 person-years) and 782,000 deaths (8.5 deaths per 100,000 person-years) in 2018.(Bray F et al., 2018) In Egypt, it represents the fourth common cancer and the leading cause of mortality- and morbidity-related cancer .(Akinyemiju T, et al.T 2017) Many hospital based studies reported increasing the incidence of HCC The reason for increased incidence could be attributed to improvement in screening programs and diagnostic tools, increasing the survival rate of cirrhotic patients that increases the chance of developing HCC . (Ibrahim AS, et al 2014) Because the early stage disease is usually asymptomatic, approximate half of patients are diagnosed at an advanced stage. Many biomarkers, such as α-fetoprotein (AFP) have already been used to screen for HCC and choose the best treatment on an individual status. However, these biomarkers are not sufficient to predict prognosis accurately. (Kabbach G, 2015) Ferritin, as a soluble iron-storage protein, participates in iron metabolism and accumulation, which directly damage DNA and proteins by generating reactive species and cause apoptosis through activation of the caspase cascade and hyperoxidation of fatty chains(Miyanishi K et al., 2019). Additionally, it is believed to be responsible for enhanced production of collagen and liver fibrosis . (Wang W et al., 2010) Elevated serum ferritin is frequently observed among patients with liver injury, regardless of etiology. (Wong K, Adams PC, 2006) However, whether ferritin is associated with incident liver cancer remains unclear. On one hand, previous clinical and epidemiologic studies show that serum ferritin may be correlated with liver cancer risk. For example, a recent meta-analysis including nine studies showed that higher serum ferritin was associated with 1.5-fold increases in risk of liver cancer. (Tran KT et al., 2019) On the other hand, the serum ferritin levels were associated with liver cancer among HCV+ men but not women in a Japanese cohort study. (Uchino K et al 2016 ) Moreover, no study has evaluated association between serum ferritin levels and the severity of hepatic decompensation in cirrhotic patients. Therefore, we will carry out a case-control study in Al Rajhy Liver Hospital, Assiut University, to examine the association between serum ferritin concentration and the incidence of HCC and severity of hepatic impairment in subjects with liver cirrhosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    102 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Association Between Serum Ferritin Level and Severity of Liver Disease and Development of HCC in Cirrhotic Patients.
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Association between serum ferritin level and severity of liver disease and development of HCC in cirrhotic patients . [One year]

      The relation between serum ferritin level and severity of liver disease and development of HCC in cirrhotic patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients with liver cirrhosis of both sexes with and without HCC regardless of the aetiology of chronic liver disease
    Exclusion Criteria:
    • Patients less than 18 years Previously treated HCC patients with no evidence of recurrence or residual activity Subjects who had received blood transfusions or iron supplements during the previous 3 months.

    Other conditions associated with elevated serum ferritin e.g., malignancy other than HCC, iron overload syndromes, autoimmune disorders, chronic excess alcohol consumption and acute and chronic infections.

    Patients who will refuse to give a written consent, will be excluded from our study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Hany Faheem Fadl allh, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05401890
    Other Study ID Numbers:
    • Serum ferritin level
    First Posted:
    Jun 2, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 26, 2022