NCT05401890

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 30, 2022

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

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

    One year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with liver cirrhosis of both sexes with and without HCC regardless of the aetiology of chronic liver disease

You may qualify if:

  • Patients with liver cirrhosis of both sexes with and without HCC regardless of the aetiology of chronic liver disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. (2018) 68:394-424.doi: 10.3322/caac.21492 . Akinyemiju T, Abera S, Ahmed M, Alam N, Alemayohu MA, Allen C, et al.The burden of primary liver cancer and underlying etiologies from 1990 to 2015 at the global, regional, and national level. JAMA Oncol. 2017;3:1683-91.https://doi.org/10.1001/jamaoncol.2017.3055. Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in Egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971.https://doi.org/10.1155/2014/437971 . Kabbach G, Assi HA, Bolotin G, et al. Hepatobiliary Tumors: Update on Diagnosis and Management. J Clin Transl Hepatol 2015;3:169-81. Miyanishi K, Tanaka S, Sakamoto H, Kato J. The role of iron in hepatic inflammation and hepatocellular carcinoma.Free Radic. Biol. Med.2019;133: 200-5. Wang W, Knovich MA, Coffman LG, Torti FM, Torti SV. Serum ferritin: past, present and future.Biochim. Biophys. Acta2010;1800:760-9. Wong K, Adams PC. The diversity of liver diseases among outpatient referrals for an elevated serum ferritin.Can. J. Gastroenterol.2006;20:467-70. Tran KT, Coleman HG, McCain RS, Cardwell CR. Serum biomarkers of iron status and risk of primary liver cancer: a systematic review and meta-analysis.Nutr. Cancer2019;71: 1365-73. Uchino K, Tateishi R, Fujiwara Net al. Impact of serum ferritin level on hepatocarcinogenesis in chronic hepatitis C patients.Hepatol. Res.2016;46: 259-68.

    RESULT

Central Study Contacts

Ashraf Mahmoud Osman

CONTACT

Ahmed Shawkat Abdelmohsen

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 2, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

July 26, 2022

Record last verified: 2022-05