The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1... | NCT06328283

Studies
The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients

NCT06328283

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Mar 25, 2024Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

measure of Glutamine synthetase and BCLFAF1

Countries

Egypt

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Mar 18, 2024

First Submission Date that Met QC Criteria

Mar 18, 2024

First Posted Date

Mar 25, 2024Actual

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

Mar 18, 2024

Last Update Posted Date

Mar 25, 2024Actual

Description Module

Brief Summary

Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.

HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015).

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases group		cirrhotic patients with early hepatocellular carcinoma	Other: measure of Glutamine synthetase and BCLFAF1
control group		cirrhotic patients with no hepatocellular carcinoma	Other: measure of Glutamine synthetase and BCLFAF1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measure of Glutamine synthetase and BCLFAF1	Other	compare Glutamine synthetase and BCLFAF1 in cases and controls	cases group control group

Measure	Description	Time Frame
glutamine synthetase	to detect early HCC IN CIRRHOTIC	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:

Group I:

The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion as control group. Cirrhosis will be determined according to clinical , sereological ,radiological findings.

Group II:

The study group will include 45 patient with HCC on top of liver cirrhosis .All causes of liver cirrhosis will be accepted .HCC will be assessed by triphasic CT or MRI or histological validation .In these group we will take patients with liver cirrhosis with early hepatocellular carcinoma that defined as tumors smaller than 3cm and three or fewer in number at stage A according to BCLC staging also sometimes it includes solitary tumors up to 5 cm in size as defined in the Milan criteria. Both very early and early stage tumors are relatively small but both are hyper vascular in arterial phase.

Exclusion Criteria:

Non cirrhotic patients.
Patients with distant metastasis.
Patients aged below18 years.
Patients with other malignancy rather than HCC.
Patients with late stage of HCC.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

- A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:

Group I:

The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion

Group II:

The study group will include 45 patient with HCC on top of liver cirrhosis .

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Esraa s ABDELRHMAN, assistant lecutrer	Contact	01000496350		esraa.ahmed1@med.sohag.eg
mahmoud s el eslam, professor	Contact

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university Hospital		Sohag	Sohagm		Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34270844	Background	Mir IH, Guha S, Behera J, Thirunavukkarasu C. Targeting molecular signal transduction pathways in hepatocellular carcinoma and its implications for cancer therapy. Cell Biol Int. 2021 Nov;45(11):2161-2177. doi: 10.1002/cbin.11670. Epub 2021 Aug 1.
33033565	Background	Singh G, Yoshida EM, Rathi S, Marquez V, Kim P, Erb SR, Salh BS. Biomarkers for hepatocellular cancer. World J Hepatol. 2020 Sep 27;12(9):558-573. doi: 10.4254/wjh.v12.i9.558.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type