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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring glypican 3

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 13, 2020
    Last Updated
    January 11, 2022
    Sponsor
    Assiut University
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    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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    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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    Citation
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    Citation
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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

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    Assessment of Glypican 3 as Apredictive Marker in Colorectal Cancer Patients

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