Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma

November 7, 2017 updated by: Nourhan Yousef, Assiut University
Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) represents the commonest primary cancer of the liver. Incidence is increasing and HCC has risen to become the 5th commonest malignancy worldwide and the third leading cause of cancer related death, exceeded only by cancers of the lung and stomach. HCC prevalence is higher in sub-Saharan Africa, central and Southeast Asia.Serum lactate dehydrogenase (LDH) levels is an indirect marker of tumor hypoxia, angioneogenesis and worse prognosis. Lactic dehydrogenase (LDH), which is a glycolytic enzyme, composed of four polypeptide chains, each one encoded by separate gene (M and H), exists in various types of human tissue and neoplasms. LDH is a key enzyme in the conversion pyruvate to lactate under anaerobic conditions .Five isoforms of LDH have been identified as a result of the five different combinations of polypeptide subunits.

Hypoxia represents a clinical biological mechanism for treatment resistance in cancer cells via the formation of new blood vessels. Furthermore, a growing body of evidence indicates that hypoxia might actually promote cancer development.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients resident at oncology department at luxor international hospital who diagnosed as apatient with Hepatocellular carcinoma

Description

Inclusion Criteria:

  • patients with Hepatocellular carcinoma diagnosed by biopsy or imaging criteria and alpha feto protein.
  • signed informed consent before registration in study
  • Eastern Cooperative oncology Groups Performance status between 0 and 2.

Exclusion Criteria:

  • Cachexia or poor condition
  • pregnant or human chorionic gonadotropin positive
  • patient with another liver tumor
  • Any previous treatment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients with Hepatocellular carcinoma who treated with sorafenib and measure LDH serum level one month pre and post treatment
Other: LDH serum level
Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome
Group B
Patients with Hepatocellular carcinoma who treated with trans catheter arterial chemo embolization (TACE) and measure LDH serum level one month pre and post treatment
Other: LDH serum level
Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome
Group C
Patients with Hepatocellular carcinoma who treated surgically and measure LDH serum level one month pre and post treatment
Other: LDH serum level
Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome
Group D
Patients with Hepatocellular carcinoma who don't receive treatment and asses LDH serum level for 3months
Other: LDH serum level
Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum LDH level as a predictor of response in hepatocellular carcinoma
Time Frame: 2 months
To evaluate if serum LDH level can be used as a predictor of response in patients receiving different lines of treatment for hepatocellular carcinoma
2 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Aml R Ibrahim, Lecturer, Assiut University

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 (Anticipated)

January 2, 2018

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 17, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URL

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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