Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma

• Sponsor: Mansoura University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03206866
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Role of Serum Regucalcin in Diagnosis of HCC	Diagnostic Test: serum regucalcin antibody

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 96 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma
• Actual Study Start Date: Dec 30, 2016
• Anticipated Primary Completion Date: Dec 30, 2017
• Anticipated Study Completion Date: Dec 30, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Center Mansoura University	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Ahmed_Elalfy, medical oncology resident, Mansoura University
• ClinicalTrials.gov Identifier: NCT03206866
• Other Study ID Numbers: SMP30
• First Posted: Jul 2, 2017
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Disease; Antibodies

Study Results

No Results Posted as of Jul 2, 2017