Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients

April 26, 2023 updated by: Hala Maher Abdelhafiz, Sohag University
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Changing epidemiology of HCC is related to trends in these risk factors, Paraneoplastic syndromes (PNS) are defined as systemic, metabolic, or other distant consequences of malignancy resulting, either directly or indirectly, from production by the neoplasm of substances that gain access to the blood stream, thereby exerting their effects on distant organs or tissues There is four major HCC-associated paraneoplastic syndromes among Cirrhotic patients,i.e.hypercholesterolemia,hypoglycemia,hypercalcemia,and erythrocytosis .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amr M Zaghloul, Assistant professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • Cirrhotic Patients with HCC.
  • HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.

Description

Inclusion Criteria:

  • - Cirrhotic Patients with HCC.
  • HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.

Exclusion Criteria:

  • - Patient known to have primary parathyroid disease, patients with bone metastasis or excessive use of antacids.
  • Patients with secondary polycythemia (as chronic hypoxia) and patients with polycythemia rubra vera.
  • Patients with acute infections or GIT bleeding.
  • Patients with preexisting dyslipidemia.
  • Patients with significant cholestasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the prevalence of Paraneoplastic Syndrome in cirrhotic Patients with HCC.
Time Frame: 12 months
To investigate the prevalence of PNS (hypoglycemia, hypercholesterolemia, hypercalcemia, erythrocytosis, and thrombocytosis) and clinical characteristics in cirrhotic Patients with HCC.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-12MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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