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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338166
Recruitment Status : Unknown
Verified November 2017 by Nourhan Yousef, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Nourhan Yousef, 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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Other: LDH serum level

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma
Estimated Study Start Date : January 2, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients resident at oncology department at luxor international hospital who diagnosed as apatient with Hepatocellular carcinoma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338166


Contacts
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Contact: Samir S Mohammed, Professor 00201222302375 samir_eid@hotmail.com
Contact: Marwa I Khalaf, Lecturer 00201201777338 esmail_marwa@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Aml R Ibrahim, Lecturer Assiut University
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Responsible Party: Nourhan Yousef, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03338166    
Other Study ID Numbers: URL
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases