Assessment of Glypican 3 as Apredictive Marker in Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glypican 3
Sponsored by

About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring glypican 3
Eligibility Criteria
Inclusion Criteria:
- Patients with colorectal cancer and admitted to south egypt cancer institute .
Exclusion Criteria:
- Other malignant diseases .
- Patients received chemotherapy for colorectal cancer .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
patients with colorecta cancer
healthy individuals
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of Glypican 3 role as a predictive and diagnostic marker of colorectal marker .
measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method
Secondary Outcome Measures
Addition of Glypican 3 to the routine markers of colorectal cancer . - Correlatin of this marker with the disease pathology and management procedures .
measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04728139
Brief Title
Assessment of Glypican 3 as Apredictive Marker in Colorectal Cancer Patients
Official Title
Assessment of Glypican 3 as a Predictive Marker in Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation Of Glypican 3 in serum of colorectal cancer patients .
Correlation between Glypican 3 and clinicopathological characteristics of colorectal cancer .
Detailed Description
Colorectal cancer (CRC) is the third most common malignancy and the fourth most prominent cause of cancer-related deaths worldwide. Also it is the 7th commonest cancer in Egypt, representing 3.47% of male cancers and 3% of female cancers.The Glypicans , a family of proteins classified as HSPGs (heparan sulfate proteoglycan) , have been shown to interact with a number of growth factors and modulate growth factor activity and are linked to the xtracellular side of cell membrane by a glycosylphosphatidylinositol (GPI) anchor . Members of this large family of transmembrane proteins have been identified in both mammals and drosophila: 6 glypicans (GPC-1 through GPC-6) in mammals, and two others in the fly .Glypican-3 (GPC3) as one of this family is a protein of about 70 kD . It has multiple sugar chains and heparan sulfate modification sites . These proteins (Glypicans) participate in organ development by modulating extracellular growth signals and morphogen gradient formation, and are involved in human overgrowth and skeletal dysplasia problems .In some cancers, they are highly expressed, associated with tumorigenesis, and regulating angiogenesis for cancer progression and invasion . Abnormal expression of glypicans has been noted in multiple types of cancer. For examples, GPC-1 expression was found to be increased in breast cancer tissues and ovarian malignant tumors .GPC-2 is associated with neuroblastoma .Expression of GPC-3 was found in high-grade urothelial carcinoma and also reported in some non-CNS tumors of the brain.There have been several reports about the clinical usefulness of the N-terminal form of GPC3. Enzyme-linked immunosorbent assay methods capable of detecting the N-terminal form of GPC3 . A study of colorectal cancer tissue speciment shows a correlation between expression of GPC3 with the clinicopathologic variables such as the level of differentiation, GPC3 was found to be expressed in ( 42.8% ) of the well-differentiated tumors, and (50%) of the moderately differentiated tumors, (75%) of the moderately and poorly differentiated tumors .Therefore, it was found that the expression of GPC3 was correlated with the pathological grade of the tumors .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
glypican 3
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with colorecta cancer
Arm Type
Active Comparator
Arm Title
healthy individuals
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
glypican 3
Intervention Description
Assessment of glypican 3 presence in colorectal cancer patients using ELISA
Primary Outcome Measure Information:
Title
Evaluation of Glypican 3 role as a predictive and diagnostic marker of colorectal marker .
Description
measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Addition of Glypican 3 to the routine markers of colorectal cancer . - Correlatin of this marker with the disease pathology and management procedures .
Description
measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with colorectal cancer and admitted to south egypt cancer institute .
Exclusion Criteria:
Other malignant diseases .
Patients received chemotherapy for colorectal cancer .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Hany Mohammed
Phone
01118441744
Email
rehamhany809@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hosney Badrawy Hamed
Phone
01060664976
Email
BadranH@yahoo.com
12. IPD Sharing Statement
Citations:
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20420949
Citation
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://rehamhany809@gmail.com
Learn more about this trial
Assessment of Glypican 3 as Apredictive Marker in Colorectal Cancer Patients
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