Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma

June 29, 2017 updated by: Ahmed_Elalfy, Mansoura University

Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or therapeutic targets.

SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identified from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular carcinoma associated antigens [4]

Serum antibody response to SMP30 in various patients using the methods of Western-blot and ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in the one with alpha-fetoprotein (AFP) negative

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

96

Contacts and Locations

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

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Oncology center Mansoura University
        • Contact:
          • maha zaafarany, professor
          • Phone Number: 01001996798
        • Contact:
          • sameh samaa, professor
          • Phone Number: 01001009510

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients will be subjected to the following:

  • Detailed History taking.
  • Physical examination.

  • Routine laboratory investigations essential for diagnosis and follow up of patients including:

    1. Complete blood count (CBC).
    2. Chemistry profile: serum bilirubin-serum albumin-SGPT-SGOT.
    3. serum regucalcin(SMP30) antibodies using ELISA
    4. AFP level.
  • Radiological assessment:

US, Triphasic CT to assess (tumor site, size, numbers, nodal metastases, distal metastases, portal vein invasion..)

Description

Inclusion Criteria:

  1. Newly diagnosed cases of HCC (be based on NCCN guidelines triphasic CT and AFP or liver biopsy)
  2. Adult patients
  3. Both genders are eligible.
  4. Informed consent obtained from subject or subject's legal representative

Exclusion Criteria:

  1. Patient with other malignancies.
  2. Patients with advanced comorbidities except for renal failure.
  3. Prior chemotherapy

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
patients with HCC
Diagnostic test: serum regucalcin antibody
serum regucalcin antibody
patients with hepatitis C Ab positive
Diagnostic test: serum regucalcin antibody
serum regucalcin antibody
patients with hepatitis C Ab negative
Diagnostic test: serum regucalcin antibody
serum regucalcin antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum regucalcin in HCC patients
Time Frame: 1-12-2016 to 1-12-2017

This work aims to assess serum regucalcin antibodies level using ELISA in HCC patients to:

  • evaluate its potential role as biomarker in diagnosis.
  • evaluate potential associations of the presence of serum regucalcin antibody with HCC patients' clinico-epidemiological parameters.
1-12-2016 to 1-12-2017

Collaborators and Investigators

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

Sponsor

Mansoura 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.

Helpful Links

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)

December 30, 2016

Primary Completion (ANTICIPATED)

December 30, 2017

Study Completion (ANTICIPATED)

December 30, 2017

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMP30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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