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

NCT ID: NCT03338166

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Patients with Hepatocellular carcinoma who treated with sorafenib and measure LDH serum level one month pre and post treatment

LDH serum level

Intervention Type OTHER

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

LDH serum level

Intervention Type OTHER

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

LDH serum level

Intervention Type OTHER

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

LDH serum level

Intervention Type OTHER

Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome

Interventions

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LDH serum level

Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nourhan Yousef

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aml R Ibrahim, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Samir S Mohammed, Professor

Role: CONTACT

Phone: 00201222302375

Email: [email protected]

Marwa I Khalaf, Lecturer

Role: CONTACT

Phone: 00201201777338

Email: [email protected]

Other Identifiers

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URL

Identifier Type: -

Identifier Source: org_study_id