Golgi Protein for HCC Diagnosis | NCT03039322

Studies
Golgi Protein for HCC Diagnosis

NCT03039322

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Feb 1, 2017Estimated

Enrollment

90Actual

Phase

Not provided

Conditions

Screening for Hepatocellular Carcinoma

Interventions

Serum Golgi Protein 73

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2014Actual

Primary Completion Date

Dec 30, 2015Actual

Completion Date

Dec 30, 2015Actual

First Submitted Date

Jan 31, 2017

First Submission Date that Met QC Criteria

Jan 31, 2017

First Posted Date

Feb 1, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This case-control study was conducted on 90 patients who were equally divided into two groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using ELISA technique

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCC			Diagnostic Test: Serum Golgi Protein 73
liver cirrhosis No HCC			Diagnostic Test: Serum Golgi Protein 73

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum Golgi Protein 73	Diagnostic Test	Serum test	HCC liver cirrhosis No HCC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Golgi protein correlated with presence of HCC		within one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients were older than 18 years.

Exclusion Criteria:

patients with hepatic focal lesions not due to HCC such as Hemangioma, Hepatic cyst, and liver metastases; patients infected with HIV; patients with any autoimmune disease; or patients with metastatic disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Group I: Included 45 patients with liver cirrhosis due to HCV infection. Liver cirrhosis was diagnosed clinically, laboratory, and radiologically. Chronic HCV infection was diagnosed by positive HCV antibody and positive quantitative HCV PCR.

Group II: Included 45 patients with Hepatocellular carcinoma (HCC) on top of HCV cirrhosis diagnosed by two imaging modalities, abdominal ultrasound and the characteristic arterial enhancement and venous washout in Tri-phasic CT abdomen.

Sampling Method

Non-Probability Sample