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Assessment of Glypican 3 as Apredictive Marker in Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT04728139
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Reham Hany Mohammed, Assiut University

Study Description
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Brief Summary:
  • Evaluation Of Glypican 3 in serum of colorectal cancer patients .
  • Correlation between Glypican 3 and clinicopathological characteristics of colorectal cancer .

Condition or disease Intervention/treatment Phase
Colorectal Cancer Diagnostic Test: glypican 3 Not Applicable

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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Assessment of Glypican 3 as a Predictive Marker in Colorectal Cancer Patients
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : October 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: patients with colorecta cancer Diagnostic Test: glypican 3
Assessment of glypican 3 presence in colorectal cancer patients using ELISA
No Intervention: healthy individuals


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Glypican 3 role as a predictive and diagnostic marker of colorectal marker . [ Time Frame: 3 years ]
    measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method


Secondary Outcome Measures :
  1. Addition of Glypican 3 to the routine markers of colorectal cancer . - Correlatin of this marker with the disease pathology and management procedures . [ Time Frame: 3 years ]
    measurment of GLYPICAN 3 level in serum of colorectal patients using ELISA method


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728139


Contacts
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Contact: Reham Hany Mohammed 01118441744 rehamhany809@gmail.com
Contact: Hosney Badrawy Hamed 01060664976 BadranH@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Reham Hany Mohammed, residet doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04728139    
Other Study ID Numbers: colorectal cancer
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reham Hany Mohammed, Assiut University:
glypican 3
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases