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

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: LDH serum level

• Registration Number: NCT03338166
• Lead Sponsor: Assiut University

Brief Summary

Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.

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 Timeline

• Study First Submitted: 2017-06-17
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Study First Posted: 2017-11-09
• Last Update Posted: 2017-11-09
• Study Start: 2018-01-02
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	LDH serum level	Patients with Hepatocellular carcinoma who treated with trans catheter arterial chemo embolization (TACE) and measure LDH serum level one month pre and post treatment
Group A	LDH serum level	Patients with Hepatocellular carcinoma who treated with sorafenib and measure LDH serum level one month pre and post treatment
Group C	LDH serum level	Patients with Hepatocellular carcinoma who treated surgically and measure LDH serum level one month pre and post treatment
Group D	LDH serum level	Patients with Hepatocellular carcinoma who don't receive treatment and asses LDH serum level for 3months

Primary Outcome Measures

Name	Time	Method
serum LDH level as a predictor of response in hepatocellular carcinoma	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