Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma

• Conditions: Role of Serum Regucalcin in Diagnosis of HCC
• Interventions: Diagnostic Test: serum regucalcin antibody

• Registration Number: NCT03206866
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with HCC	serum regucalcin antibody	-
patients with hepatitis C Ab negative	serum regucalcin antibody	-
patients with hepatitis C Ab positive	serum regucalcin antibody	-

Primary Outcome Measures

Name	Time	Method
serum regucalcin in HCC patients	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.

Trial Locations

Locations (1)

Oncology Center Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt